Sign the petition attached to the text of this Open Letter to CFM (Brazilian Federal Council of Medicine) and the Brazilian Regional Councils of Medicine, at the address of this link:
This text represents the public position of patients with autoimmune diseases who are or have been treated with high doses of the hormone D3 (“vitamin” D3), as well as of their families, friends of patients and people in general. This therapeutic approach is a medical practice updated according to current scientific knowledge provided by the “Human Genome Project” and is disconnected from any interests unrelated to the patient’s health. It deals with the causes of diseases and not only with their effects, but it has faced notorious and persistent hostility from Brazilian medicine managers against the doctors who are providing their patients with autoimmune disease a return to a normal life, and the knowledge necessary to prevent progression of disabilities. “Vitamin” D is actually a hormone (from the same family of steroid hormones as estrogen, progesterone, testosterone, and cortisol) and is given in higher doses to counteract the genetic resistance that these patients have to its biological effects (including its fundamental role in immune regulation).
Calcidiol = 25 (OH) D. Cholecalciferol (or “vitamin” D3) is transformed by the body into calcidiol [or calcifediol, or 25 (OH) D] – the form of vitamin D that is measured in laboratory tests after obtaining “vitamin” D3 by ingestion or during direct skin exposure sunlight. Calcidiol [25 (OH) D] is ultimately transformed into 1.25 (OH) 2D3 (calcitriol), which is the active form of “vitamin” D.
The Brazilian Federal Constitution of 1988, in its Art. 6, establishes the right to health among the fundamental social rights. According to its Article 196, health is to be considered as a fundamental “everyone’s right and the duty of the State, guaranteed through social and economic policies that should aim at reducing the risk of disease and other injuries, as well as universal and equal access to health care, actions and services for health promotion, protection and recovery” (emphasis added).
Within the scope of Brazilian administrative law, CFM and Councils are categorized as Autarchies, a type of indirect public administration entity, created by specific law, with legal personality under internal public law, its own assets and specific state attributions (emphasis added). Therefore, the actions and omissions of these Autarchies are governed by the Arts. 6 and 196 of the Brazilian Federal Constitution.
Reproduction of this text in any media or means of dissemination is prohibited except through the link on the page or the share buttons at the end of this Open Letter to preserve the source of the text. On 08.02.2021
What gives the status of scientific value to a particular medical subject is its publication in indexed scientific journals with peer-reviewed content in the international medical community. In the case of the hormone D3, there are hundreds of thousands cumulated over decades, which could never be ignored by CFM and Regional Councils of Medicine, in contrast with what has happened.
At the beginning of the year 2021, there are about 285,000 scientific publications on the role of “vitamin” D3 as a regulator of the immune system, as the figure below demonstrates – a photo of a Google Scholar page on the subject – and can be checked by searching for the entries “Vitamin D” and immune system:
There are 285,000 publications listed for the “Vitamin D” immune system search criteria, in the Scholar Google database. Whoever says that “there are no scientific publications” is not telling the truth. Search made in January 2021.
The “disciplinary / punitive” way in which the Brazilian Medical Councils (which claim to be followers of “Science”) deal with a subject of this importance for health and human lives, deal with doctors who are working based on knowledge of latest scientific information (obviously, the obligation of all these professionals), characterizes an inquisitive, repressive conduct towards scientifically based medical practice. And it allows analyzing the incidence of Article 132 of the Brazilian Penal Code (putting the health and life of others at risk) and its criminal developments in cases where the damage does occur, on the part of managers who penalize the use of information from the existing scientific medical literature.
What interests are being benefited by this imposition of total ignorance on the medical profession?
In the case at hand, the legal issue is greatly aggravated by the fact that we are not dealing with a “drug”, or a “nutrient”, but with a hormone with receptors in all cells of the human body. As a hormone produced by the human organism, “vitamin D” is an indisputable biological necessity, and resumption of its physiological roles would not even need “official recognition”, leaving only the “quantum” to be autonomically evaluated by the doctor who evaluates the clinical condition of the patient under his care.
Correcting deficiencies and compensating for resistances to a hormone (caused by genetic polymorphisms) are doctor’s duties. Patients on social networks have agreed to name this medical approach as “Coimbra Protocol” on their own initiative. Such therapeutic approach in fact is scientifically based, as can be seen below.
For safety reasons, with the objective of maintaining normal serum levels of calcium and avoiding impairment of renal function, the aforementioned therapeutic approach demands that the patient should follow a diet free of excessive amounts of calcium and maintain abundant hydration. Periodic laboratory tests are carried out with the aim of making sure that parathyroid hormone (PTH) remains at normal levels (not been suppressed by vitamin D, as PTH suppression would bring the risk of hypercalcemia).
In January 2021, about 285,000 scientific publications listed in Scholar Google database already document the role of “vitamin” D (actually a secosteroid hormone, as documented since the 1930s – about 90 years ago) in the regulation of the immune system, preventing or minimizing autoimmune aggression and potentiating the reaction against infections.
It is important to note that studies with high doses of “Vitamin D” are not new, since back in 1935 it was already known about the possible effect of “Vitamin D” in autoimmune diseases.
In a double-blind clinical trial conducted in Scandinavia (Brohult and Jonson, 1973) including 49 patients with rheumatoid arthritis, cholecalciferol, the prototypical form of secosteroid, was administered at a dose of 100,000 IU per day for 1 year to 24 patients, while the remaining 25 patients received placebo. Objective and subjective improvements were observed in 67% of the group treated with cholecalciferol and in 36% of the control group, while objective and subjective deteriorations were observed in 4% of the group that received cholecalciferol and in 32% of the control group. There was a significant improvement in inflammatory markers in the group that received cholecalciferol. The consumption of analgesics and anti-inflammatory drugs decreased significantly in the cholecalciferol group and, after 1 year, morning stiffness decreased and hand strength increased in this group. In this study, there was no case of hypercalcemia, indicating resistance to the biological effects (including calcemic effects) of the “vitamin” D. As subsequent studies have suggested (thanks to the results of the Human Genome Project, discussed later) such resistance is genetically determined, that is, due to the presence of polymorphic genes on which “vitamin” D depends to produce its effects.
Brohult, Johan, and Bertil Jonson. “Effects of large doses of calciferol on patients with rheumatoid arthritis: a double-blind clinical trial.” Scandinavian Journal of Rheumatology 2.4 (1973): 173-176.
The following is a review study on the immunoregulatory effects of “vitamin” D in multiple sclerosis.
Correale, Jorge, María Célica Ysrraelit, and María Inés Gaitán. Immunomodulatory effects of Vitamin D in multiple sclerosis. Brain 132.5 (2009): 1146-1160.
There follows a study showing that, regardless of the presence of “vitamin” D deficiency, treatment with “vitamin” D may contribute to remyelination, promoting the proliferation of oligodendrocyte precursor cells (cells that produce the myelin sheath).
Gomez-Pinedo, Ulises, et al. Vitamin D increases remyelination by promoting oligodendrocyte lineage differentiation. Brain and behavior 10.1 (2020): e01498.
The so-called Human Genome Project, considered the largest research project ever carried out in the entire biological area, developed by an international consortium that involved several countries and carried out between 1990 and 2003 – see comment below – demonstrated that patients with autoimmune diseases are carriers of variants of genes (genetic polymorphisms) – that affect the genes that the “vitamin” D needs to produce their effects, including (A) the “vitamin” D receptor gene, VDR – found in virtually every cell in the body human; (B) the gene of the vitamin D activating enzyme: 1-alpha-hydroxylase – which today is recognized to be expressed by the cells of various tissues and systems (among which the cells of the immune system stand out, for their relevance to this discussion); and (C) the “vitamin” D globulin gene, DBP – or “D-Binding Protein”.
These genetic changes indicate that patients with autoimmune diseases are resistant to the biological effects of “vitamin” D. For example, a receptor (VDR) whose gene is polymorphic has its morpho-functional configuration altered, losing part of the affinity for its agonist and leading to partial resistance to biological effects of “vitamin” D (including immunoregulation).
A 2020 systematic review and meta-analysis follows, showing that genetic polymorphisms of the vitamin D receptor are associated with a significantly higher risk of developing Multiple Sclerosis.
Mohammadi, Asadollah, et al. Vitamin D receptor genetic polymorphisms and the risk of multiple sclerosis: A systematic review and meta-analysis. Steroids (2020): 108615.
A further systematic review and meta-analysis, from 2020, follows, and also shows that some vitamin D receptor polymorphisms increase susceptibility to rheumatoid arthritis.
Bagheri-Hosseinabadi, Zahra, et al. Vitamin D receptor (VDR) gene polymorphism and risk of rheumatoid arthritis (RA): systematic review and meta-analysis. Clinical Rheumatology, 2020.
This is followed by a third meta-analysis, also published in 2020, which shows that these genetic changes of the vitamin D receptor are associated with an increased risk of developing rheumatoid arthritis and systemic lupus erythematosus.
Zhang, W-T., T-F. Jin, and L. Chen. Associations of four common VDR polymorphisms with rheumatoid arthritis and systemic lupus erythematosus: evidence from a meta-analysis. Lupus 29.4 (2020): 364-370.
A fourth meta-analysis follows, showing that genetic defects in the “vitamin” D receptor are associated with an increased risk for vitiligo, just as vitamin D deficiency has also been shown to be associated.
Zhang, Jing-Zhan, et al. Vitamin D receptor gene polymorphism, serum 25-hydroxyvitamin D levels, and risk of vitiligo: A meta-analysis. Medicine 97.29, 2018.
The same occurs in relation to allergic diseases, such as asthma and atopic dermatitis, as shown in the following fifth meta-analysis on VDR polymorphisms.
Zhang, Li, et al. VDR Gene Polymorphisms and Allergic Diseases: Evidence from a Meta-analysis. Immunological Investigations 49.1-2 (2020): 166-177.
Therefore, “vitamin” D is shown to be a fundamental regulating factor in the activity of the immune system in these diseases, and resistance to the effects of “vitamin” D caused by these genetic changes can be counterbalanced with the use of higher doses of vitamin D, as explained in Dr. Danilo Finamor’s doctoral thesis mentioned below (published in an international journal after peer review).
In addition, studies have shown that the daily doses usually recommended (400 IU-600 IU) are unable to significantly modify serum levels – as published by Heaney et al. 2003 – see chart reproduced below – where mmol/L of “vitamin” D can be converted to ng/mL dividing mmol/L by 2.5.
Heaney RP, Michael Davies K, Chen TC, Holick MF, Barger-Lux MJ. Human serum 25-hydroxycholecalciferol response to extended oral dosing with cholecalciferol. The American Journal of Clinical Nutrition, Volume 77, Issue 1, January 2003, Pages 204–210.
It is emphasized in this study with the graphic reproduced above (Heaney et al., 2003) that “vitamin” D has no cumulative effect (serum levels do not rise indefinitely with the maintenance of the same daily dose) as taught for decades in medical schools (a false belief still dominant in the medical profession despite the fact that the contrary was published 18 years ago) and that the doses currently “recommended” (by IOM – “Institute of Medicine”, since October 2010 of 600 IU per day), already had been shown to be insufficient to normalize serum levels of 25 (OH) D, considering it the minimum serum level recommended by the US Endocrine Society (USA) of 40 ng / ml. Thus, in the graph reproduced above, the values of 50, 100, 150, 200 and 250 mmol / L correspond respectively to 20, 40, 60, 80 and 100 ng / mL, the latter being used by Brazilian clinical laboratories (conversion factor: 2.5). The graph shows that even almost twice (1,000 IU per day) the recommended daily dose (600 IU per day) little or nothing changes the serum level, and the study by Heaney et al (2003) was already published seven years before the I.O.M. increased the recommended daily dose from 200 IU to only 600 IU for adults.
Therefore, it is no longer possible to exclude the beneficial effects of higher doses of “vitamin” D in the treatment of autoimmune diseases such as multiple sclerosis, according to the randomized double-blind study by Soilu-Hänninen et al. (2012) and Åivo et al. (2012).
Soilu-Hänninen, Merja, et al. A randomized, double blind, placebo-controlled trial with vitamin D3 as an add on treatment to interferon β-1b in patients with multiple sclerosis. Journal of Neurology, Neurosurgery & Psychiatry 83.5 (2012): 565-571.
Åivo, J., B-M. Lindsröm, and M. Soilu-Hänninen. A randomized, double-blind, placebo-controlled trial with vitamin D3 in MS: subgroup analysis of patients with baseline disease activity despite interferon treatment. Multiple sclerosis international 2012 (2012).
Follow studies that used high doses of “vitamin” D and showed a beneficial effect in reducing the number of new lesions in Magnetic Resonance Imaging images.
Raymond Hupperts, Joost Smolders, Reinhold Vieth, Trygve Holmøy, Kurt Marhardt, Myriam Schluep, Joep Killestein, Frederik Barkhof, Manolo Beelke, Luigi M.E. Grimaldi, on behalf of the SOLAR Study Group. Randomized trial of daily high-dose vitamin D3 in patients with RRMS receiving subcutaneous interferon β-1a. Neurology Nov 2019, 93 (20) e1906-e1916.
Kimball, Samantha M., et al. Safety of vitamin D3 in adults with multiple sclerosis. The American Journal of Clinical Nutrition 86.3 (2007): 645-651.
Studies that show a reduction in the frequency of relapses in patients with multiple sclerosis treated with high doses of cholecalciferol follow.
Goldberg, P., M. C. Fleming, and E. H. Picard. “Multiple sclerosis: decreased relapse rate through dietary supplementation with calcium, magnesium and vitamin D. Medical Hypotheses 21.2 (1986): 193-200.
Laursen, Julie Hejgaard, et al. “Vitamin D supplementation reduces relapse rate in relapsing-remitting multiple sclerosis patients treated with natalizumab. Multiple Sclerosis and Related Disorders 10 (2016): 169-173.
A study follows that shows improvement in the quality of life of patients using higher doses of “vitamin” D in multiple sclerosis.
Fereshteh Ashtari, Nafiseh Toghianifar, Sayyed Hamid Zarkesh-Esfahani & Marjan Mansourian. High-dose vitamin D intake and quality of life in relapsing-remitting multiple sclerosis: a randomized, double-blind, placebo-controlled clinical trial. Neurol Res 2016 Oct; 38 (10): 888-92.
A study follows that shows that alfacalcidiol (cholecalciferol analogue) has shown to be a potent immunomodulator in patients with rheumatoid arthritis.
Andjelkovic, Z., et al. “Disease modifying and immunomodulatory effects of high dose 1 (OH) D3 in rheumatoid arthritis patients.” Clinical and experimental rheumatology 17 (1999): 453-456.
Once the predisposing genetic factor (the polymorphism) was identified, preventive actions could be proposed through the same compensatory approach. The correction of deficiency / insufficiency to non-toxic levels, but capable of producing the regulatory effects of “Vitamin” D on the immune system (higher than those necessary to avoid impairment of bone development and maintenance of bone density) is evident as preventive approach to autoimmune and infectious diseases.
The “Human Genome Project”, which consumed around 3 billion dollars of public funds from several countries, including Brazil – where the participating researchers received funds from FAPESP – São Paulo State Research Support Foundation, had precisely this objective: to provide a platform for genetic data so that researchers could, when identifying polymorphisms associated with specific diseases, propose and test new therapeutic approaches aimed at compensating for the effects of these polymorphisms, thus treating the cause and not just minimizing the manifestations of the various diseases.
Collins, Francis S., Michael Morgan, and Aristides Patrinos. The Human Genome Project: lessons from large-scale biology. Science 300.5617 (2003): 286-290.
Five years earlier (in 1999), with the Human Genome Project in full swing, the same author (Francis S. Collins) wrote, highlighting the project’s ambitions): https://www.nejm.org/doi/full/10.1056/NEJM199907013410106
Writing 97 years ago, Sir William Osler described the goals of medicine this way: “To wrest from nature the secrets which have perplexed philosophers in all ages, to track to their sources the causes of disease, to correlate the vast stores of knowledge, that they may be quickly available for the prevention and cure of disease — these are our ambitions.” (Osler W. Chauvinism in medicine. Montreal Med J 1902;31:684-699)
The Human Genome Project, with its bold goal of providing the tools to discover hereditary factors in virtually all diseases, has become the main modern component of Osler’s vision. The genetic revolution in medicine is underway.
Collins, Francis S. Shattuck Lecture – Medical and Societal Consequences of The Human Genome Project. The New England Journal of Medicine, 1999; 341: 28-37, https://www.nejm.org/doi/full/10.1056/nejm199907013410106
Collins, Francis S., Michael Morgan, and Aristides Patrinos. The Human Genome Project: lessons from large-scale biology. Science 300.5617 (2003): 286-290.
THE USE OF HIGH DOSES OF “VITAMIN” D3 FOR THERAPEUTIC PURPOSES HAS SCIENTIFIC PUBLICATION BY PAIRS REVIEW SINCE 2013
With specific reference to the so-called “Coimbra Protocol”, an expression coined by patients and family members on social networks, a PhD project by Dr. Danilo Finamor was carried out at the Federal University of São Paulo (UNIFESP), with the aim of compensating the genetic resistance of patients with autoimmune diseases through the use of higher doses of “vitamin” D.
Finamor D.C., Sinigaglia-Coimbra R., Neves L.C., et al. A pilot study assessing the effect of prolonged administration of high daily doses of vitamin D on the clinical course of vitiligo and psoriasis. “Dermatoendocrinol”. 2013; 5 (1): 222-234. doi: 10.4161 / derm.24808
The study, which is the result of Dr. Danilo Finamor’s doctoral thesis, was published in English in a medical journal of international circulation, indexed in medical databases, which uses peer review.
Thus, the clinical approach practiced by Professor Dr. Cícero Galli Coimbra and other doctors in Brazil, and by about 200 medical colleagues from Europe, the United States, Canada, Russia, India, the Middle East, Mexico and several countries in South America, is scientifically justified, the adoption of this methodology being framed in article 37 of the Declaration of Helsinki, which allows the doctor to offer his patients the treatment he deems most appropriate, and is also in line with what it stipulates first and the second fundamental principles of medical practice: the principle of non-maleficence and the principle of beneficence (making all the benefits that are available, through the knowledge acquired).
The professional ethics in force and accepted at an international level, not only allows the doctor to use a resource that, in his judgment, is capable of benefiting his patient (s), although his therapeutic method is potentially not (still) recognized as valid by other medical practitioners. This is clearly expressed in Article 37 of the Declaration of Helsinki, maintained – including with the reference article – for several decades – under the sponsorship of the World Medical Association
and reproduced below with emphasis added by the current version, issued on the occasion of the sixty-fourth General Assembly of the World Medical Association held in the city of Fortaleza, Brazil, in October 2013.
“In the treatment of a particular patient, in which there are no proven interventions or these have been ineffective, the doctor, after seeking specialized advice, having the informed consent of the patient or the legal representative, can use an unproven intervention if, in his firm conviction if such an intervention offers the hope of saving life, restoring health or alleviating suffering. This intervention must then become the object of investigation, designed to assess its safety and effectiveness. In all cases, the new information must be recorded and, where appropriate, made publicly available.”
CFM RESOLUTION No. 1,098, OF JUNE 30, 1983 – MEDICAL AUTONOMY
The Declaration of Helsinki is, since 1983, recognized by the CFM by means of CFM Resolution No. 1,098, of June 30, 1983, which reads as follows:
“When treating a patient, the doctor must be free to employ a new diagnosis and a new therapeutic measure if, in his opinion, it offers hopes of saving life, restoring health or alleviating suffering.”
AVAILABILITY BY SCIENTIFIC PUBLICATION OF THE TREATMENT OF AUTOIMMUNITY IN AN INTERNATIONAL INDEXED MAGAZINE
The use of high doses of “vitamin” D in the treatment of autoimmune disease was appropriately informed, with publication in the scientific community by peer review, through the publication of the doctoral thesis defended and approved by UNIFESP by Dr. Danilo Finamor.
Regarding the effectiveness of current treatments, mentioned in the Declaration of Helsinki: “… in which there are no proven interventions or these have been ineffective…”, in the case of autoimmune diseases, the controversy is exemplified by publications in international scientific journals, such as the American Medical Association (JAMA) 2012, where the authors conclude:
“Conclusion: Among patients with relapsing-remitting MS, administration of interferon beta was not associated with a reduction in progression of disability.”
Afsaneh Shirani, MD; Yinshan Zhao, PhD; Mohammad Ehsanul Karim, MSc; et al. Association Between Use of Interferon Beta and Progression of Disability in Patients With Relapsing-Remitting Multiple Sclerosis. JAMA. 2012; 308 (3): 247-256.
doi: 10.1001 / jama.2012.7625
a) there is the use of the data platform provided by the Human Genome Project precisely for the identification of the causes of autoimmune diseases; and
b) there is the identification of genetic polymorphisms as causes of resistance to the immunomodulatory effects of a natural hormone (the “vitamin” D), in the clinical practice of using high doses of “vitamin” D3, which is fully consistent with Ethics Medical, and the doctor’s legal obligation to supply deficiencies and with the scientific publications accumulated from the publication of the Human Genome Project, on April 14, 2003.
CFM RESOLUTION 2004/2012, ARTICLE 6, INCISES I AND VII – DOES NOT APPLY TO THE USE OF HIGH DOSES OF SECOSTEROID HORMONE D3
because the resolution typification deals with vitamins.
The “scientific evidence” existing in medical publications of the secosteroid hormone was widely documented in this Open Letter to the CFM and Brazilian Regional Councils of Medicine, and when medical professionals, the media and the general public call this hormone a “vitamin”, just for “established use through practice”, cause many distortions of reality.
“Art. 6º They lack sufficient scientific proof as to the benefit for the healthy or sick human being (emphasis added, extensive scientific proof is shown here), and for this reason the following procedures, diagnoses are prohibited from being used and disclosed in the practice of Medicine. or therapeutic, which employ:
“I – for primary and secondary prevention, doses of vitamins (emphasis added, “vitamin” D3 is a hormone), proteins, minerals and lipids that do not respect safety limits (megadoses), according to national and international standards. international (emphasis added: The US Endocrine Society provides a minimum value of 40 ng /mL and most countries consider 100 ng / mL as the upper limit of the reference range);
“VII – any anti-aging, anti-cancer, anti-arteriosclerosis or chronic-degenerative disease therapies, except in situations of diagnosed disabilities whose replacement shows evidence of scientifically proven benefits.”
It has been widely demonstrated in this Open Letter that “Vitamin D” is not a vitamin, but a secosteroid hormone, and this has been known in medicine since the 1930s, of the last century. Scientific publications on the subject are numerous and indicated in this Letter.
The medical perspective changes completely when it is studied what secosteroid hormone is, and the medical obligation is to attend to deficiencies in the context of hormonal modulation, assessed on a case-by-case basis. We emphasize: legal obligation, not an optional issue.
CFM LEGAL OPINION 04 of APRIL 03, 2020 – REITERATION OF MEDICAL AUTONOMY “LATO SENSU” OPEN TO REGIONAL COUNCILS OF MEDICINE
In this legal opinion, CFM declares, right from the start, a general rule that regulates every issue that concerns medical autonomy in general in an emphatic manner:
“In all situations (emphasis added), the principle that must, necessarily, guide the treatment of the patient is that of the doctor’s autonomy (emphasis added), as well as the enhancement of the doctor-patient relationship (emphasis added), which is the as close as possible, in order to offer the patient the best medical treatment available at the moment (emphasis added)”.
47 TESTIMONIES OF PATIENTS WITH AUTOIMMUNE DISEASES IN REMISSION
In the book “Beyond Vitamin D”, volume I, by Leda Al Debes, publisher Evidência.br, 268 pages, there are 47 testimonials from patients with autoimmune diseases, including several doctors, who report the recovery of their health through high doses of this hormone, under the care of several other doctors, by modulating your innate immunity, on which acquired immunity depends. In this first volume, there are reports from people from Germany, Brazil, United States, France, Italy and Peru
So far, 210 scientists and doctors from 33 countries have called in a Letter to Governments to increase the dose of “Vitamin” D3, with the objective of restoring the optimized level of innate immunity, on which acquired immunity depends, to face the Covid pandemic -19 and its mutations (without which even any vaccines will perform satisfactorily), with natural conditions for better preservation of human life.
210 signatories in total
127 signatories with medical degrees
109 signatories with PhDs or equivalent or higher
123 signatories with personal consumption of at least 4,000 IU per day
28 signatories with personal consumption of at least 10,000 IU per day
This letter is signed to urge all governments, doctors and health professionals around the world to immediately recommend and implement appropriate efforts for their adult populations to increase vitamin D, at least until the end of the pandemic. Brazilian doctors. There are names of expression in the international scientific community.
In these terms, translated from the link https://vitamindforall.org/letter.html the content of this Letter is expressed, with emphasis added:
“To all governments, public health officials, doctors, and healthcare workers,
“[Residents of the USA: Text “VitaminDforAll” to 50409 to send this to your state’s governor.]
“Research shows low vitamin D levels almost certainly promote COVID-19 infections, hospitalizations, and deaths. Given its safety, we call for immediate widespread increased vitamin D intakes.
“Vitamin D modulates thousands of genes and many aspects of immune function, both innate and adaptive. The scientific evidence1 shows that:
- “Higher vitamin D blood levels are associated with lower rates of SARS-CoV-2 infection.
- “Higher D levels are associated with lower risk of a severe case (hospitalization, ICU, or death).
- “Intervention studies (including RCTs) indicate that vitamin D can be a very effective treatment.
- “Many papers reveal several biological mechanisms by which vitamin D influences COVID-19.
- “Causal inference modelling, Hill’s criteria, the intervention studies & the biological mechanisms indicate that vitamin D’s influence on COVID-19 is very likely causal, not just correlation.
“Vitamin D is well known to be essential, but most people do not get enough. Two common definitions of inadequacy are deficiency < 20ng/ml (50nmol/L), the target of most governmental organizations, and insufficiency < 30ng/ml (75nmol/L), the target of several medical societies & experts.2 Too many people have levels below these targets. Rates of vitamin D deficiency <20ng/ml exceed 33% of the population in most of the world, and most estimates of insufficiency <30ng/ml are well over 50% (but much higher in many countries).3 Rates are even higher in winter, and several groups have notably worse deficiency: the overweight, those with dark skin (especially far from the equator), and care home residents. These same groups face increased COVID-19 risk.
“It has been shown that 3875 IU (97mcg) daily is required for 97.5% of people to reach 20ng/ml, and 6200 IU (155mcg) for 30ng/ml,4 intakes far above all national guidelines. Unfortunately, the report that set the US RDA included an admitted statistical error in which required intake was calculated to be ~10x too low.4 Numerous calls in the academic literature to raise official recommended intakes had not yet resulted in increases by the time SARS-CoV-2 arrived. Now, many papers indicate that vitamin D affects COVID-19 more strongly than most other health conditions, with increased risk at levels < 30ng/ml (75nmol/L) and severely greater risk < 20ng/ml (50nmol/L).1
1 The evidence was comprehensively reviewed (188 papers) through mid-June [Benskin ‘20] & more recent publications are increasingly compelling [Merzon et al ‘20; Kaufman et al ‘20; Castillo et al ‘20]. (See also [Jungreis & Kellis ‘20] for deeper analysis of Castillo et al’s RCT results.)
2 E.g.: 20ng/ml: National Academy of Medicine (US, Canada), European Food Safety Authority, Germany, Austria, Switzerland, Nordic Countries, Australia, New Zealand, & consensus of 11 international organizations. 30ng/ml: Endocrine Society, American Geriatrics Soc., & consensus of scientific experts. See also [Bouillon ‘17].
“Evidence to date suggests the possibility that the COVID-19 pandemic sustains itself in large part through infection of those with low vitamin D, and that deaths are concentrated largely in those with deficiency. The mere possibility that this is so should compel urgent gathering of more vitamin D data. Even without more data, the preponderance of evidence indicates that increased vitamin D would help reduce infections, hospitalizations, ICU admissions, & deaths.
“Decades of safety data show that vitamin D has very low risk: Toxicity would be extremely rare with the recommendations here. The risk of insufficient levels far outweighs any risk from levels that seem to provide most of the protection against COVID-19, and this is notably different from drugs. Vitamin D is much safer than steroids, such as dexamethasone, the most widely accepted treatment to have also demonstrated a large COVID-19 benefit. Vitamin D’s safety is more like that of face masks. There is no need to wait for further clinical trials to increase use of something so safe, especially when remedying high rates of deficiency/insufficiency should already be a priority.
“Therefore, we call on all governments, doctors, and healthcare workers worldwide to immediately recommend and implement efforts appropriate to their adult populations to increase vitamin D, at least until the end of the pandemic. Specifically to:
- “Recommend amounts from all sources sufficient to achieve 25(OH)D serum levels over 30ng/ml (75nmol/L), a widely endorsed minimum with evidence of reduced COVID-19 risk.
- “Recommend to adults vitamin D intake of 4000 IU (100mcg) daily (or at least 2000 IU) in the absence of testing. 4000 IU is widely regarded as safe.5
- “Recommend that adults at increased risk of deficiency due to excess weight, dark skin, or living in care homes may need higher intakes (eg, 2x). Testing can help to avoid levels too low or high.
- “Recommend that adults not already receiving the above amounts get 10,000 IU (250mcg) daily for 2-3 weeks (or until achieving 30ng/ml if testing), followed by the daily amount above. This practice is widely regarded as safe. The body can synthesize more than this from sunlight under the right conditions (e.g., a summer day at the beach). Also, the NAM (US) and EFSA (Europe) both label this a “No Observed Adverse Effect Level” even as a daily maintenance intake.
- “Measure 25(OH)D levels of all hospitalized COVID-19 patients & treat w/ calcifediol or D3, to at least remedy insufficiency <30ng/ml (75nmol/L), possibly with a protocol along the lines ofCastillo et al ‘20 orRastogi et al ’20, until evidence supports a better protocol.
“Many factors are known to predispose individuals to higher risk from exposure to SARS-CoV-2, such as age, being male, comorbidities, etc., but inadequate vitamin D is by far the most easily and quickly modifiable risk factor with abundant evidence to support a large effect. Vitamin D is inexpensive and has negligible risk compared to the considerable risk of COVID-19.
“Please Act Immediately
Sign the petition attached to the text of this Open Letter to CFM and the Regional Councils of Medicine, at the address of this link:
- fevereiro 2021 (2)