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Scientific Opinion on the substantiation of health claims related to vitamin D and normal function of the immune system and inflammatory response (ID 154, 159), maintenance of normal muscle function (ID 155) and maintenance of normal cardiovascular function (ID 159) pursuant to Article 13(1) of Regulation (E

EFSA, EFSA Journal, doi:10.2903/j.efsa.2010.1468

Feb 2010

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Vitamin D for COVID-19

8th treatment shown to reduce risk in October 2020

^*, now known with p < 0.00000000001 from 120 studies, recognized in 8 countries.

Lower risk for mortality, ICU admission, hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,100+ studies for 60+ treatments. c19early.org

European Food Safety Administration review concluding that there is a causal relationship between the intake of vitamin D and immune system function.

Reviews covering vitamin D for COVID-19 include Andrade, Arora, Basha, Brenner, Cannell, Cutolo, DiGuilio, EFSA, EFSA (B), Foshati, Gotelli, Grant, Grant (B), Grant (C), Griffin, Kohlmeier, McCullough, Mercola, Nicoll, Palacios, Quesada-Gomez, Schloss, Shah Alam, Xu.

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1. Andrade et al., Vitamin A and D deficiencies in the prognosis of respiratory tract infections: A systematic review with perspectives for COVID-19 and a critical analysis on supplementation, SciELO preprints, doi:10.1590/SciELOPreprints.839.scielo.org, doi.org.

2. Arora et al., Global Dietary and Herbal Supplement Use during COVID-19—A Scoping Review, Nutrients, doi:10.3390/nu15030771.mdpi.com, doi.org.

3. Basha et al., Is the shielding effect of cholecalciferol in SARS CoV-2 infection dependable? An evidence based unraveling, Clinical Epidemiology and Global Health, doi:10.1016/j.cegh.2020.10.005.sciencedirect.com, doi.org.

4. Brenner, H., Vitamin D Supplementation to Prevent COVID-19 Infections and Deaths—Accumulating Evidence from Epidemiological and Intervention Studies Calls for Immediate Action, Nutrients, doi:10.3390/nu13020411.mdpi.com, doi.org.

5. Cannell et al., Epidemic influenza and vitamin D, Epidemiol Infect., 2006, 134:6. 1129-40, doi:10.1017/S0950268806007175.nih.gov, doi.org.

6. Cutolo et al., Involvement of the secosteroid vitamin D in autoimmune rheumatic diseases and COVID-19, Nature Reviews Rheumatology, doi:10.1038/s41584-023-00944-2.nature.com, doi.org.

7. DiGuilio et al., Micronutrient Improvement of Epithelial Barrier Function in Various Disease States: A Case for Adjuvant Therapy, International Journal of Molecular Sciences, doi:10.3390/ijms23062995.mdpi.com, doi.org.

8. EFSA, Scientific Opinion on the substantiation of health claims related to vitamin D and normal function of the immune system and inflammatory response (ID 154, 159), maintenance of normal muscle function (ID 155) and maintenance of normal cardiovascular function (ID 159) pursuant to Article 13(1) of Regulation (E, EFSA Journal, doi:10.2903/j.efsa.2010.1468.wiley.com, doi.org.

9. EFSA (B), Scientific Opinion on the substantiation of a health claim related to vitamin D and contribution to the normal function of the immune system pursuant to Article 14 of Regulation (EC) No 1924/2006, EFSA Journal, doi:10.2903/j.efsa.2015.4096.europa.eu, doi.org.

10. Foshati et al., Antioxidants and clinical outcomes of patients with coronavirus disease 2019: A systematic review of observational and interventional studies, Food Science & Nutrition, doi:10.1002/fsn3.3034.wiley.com, doi.org.

11. Gotelli et al., Understanding the immune-endocrine effects of vitamin D in SARS-CoV-2 infection: a role in protecting against neurodamage?, Neuroimmunomodulation, doi:10.1159/000533286.karger.com, doi.org.

12. Grant, W., Vitamin D and viral infections: Infectious diseases, autoimmune diseases, and cancers, Advances in Food and Nutrition Research, doi:10.1016/bs.afnr.2023.12.007.sciencedirect.com, doi.org.

13. Grant (B) et al., A Narrative Review of the Evidence for Variations in Serum 25-Hydroxyvitamin D Concentration Thresholds for Optimal Health, Nutrients, doi:10.3390/nu14030639.mdpi.com, doi.org.

14. Grant (C) et al., Evidence that Vitamin D Supplementation Could Reduce Risk of Influenza and COVID-19 Infections and Deaths, Nutrients, 12:4, 988, doi:10.3390/nu12040988.mdpi.com, doi.org.

15. Griffin et al., Perspective: Vitamin D supplementation prevents rickets and acute respiratory infections when given as daily maintenance but not as intermittent bolus: implications for COVID-19, Clinical Medicine, doi:10.7861/clinmed.2021-0035.sciencedirect.com, doi.org.

16. Kohlmeier et al., When Mendelian randomisation fails, BMJ Nutrition, Prevention & Health, doi:10.1136/bmjnph-2021-000265.bmj.com, doi.org.

17. McCullough et al., Daily oral dosing of vitamin D3 using 5000 TO 50,000 international units a day in long-term hospitalized patients: Insights from a seven year experience, The Journal of Steroid Biochemistry and Molecular Biology, doi:10.1016/j.jsbmb.2018.12.010.sciencedirect.com, doi.org.

18. Mercola et al., Evidence Regarding Vitamin D and Risk of COVID-19 and Its Severity, Nutrients 2020, 12:11, 3361, doi:10.3390/nu12113361.mdpi.com, doi.org.

19. Nicoll et al., COVID-19 Prevention: Vitamin D Is Still a Valid Remedy, Journal of Clinical Medicine, doi:10.3390/jcm11226818.mdpi.com, doi.org.

20. Palacios et al., Is vitamin D deficiency a major global public health problem?, J Steroid Biochem Mol Biol., 2014, 144PA, 138–145, doi:10.1016/j.jsbmb.2013.11.003.nih.gov, doi.org.

21. Quesada-Gomez et al., Vitamin D Endocrine System and COVID-19: Treatment with Calcifediol, Nutrients, doi:10.3390/nu14132716.mdpi.com, doi.org.

22. Schloss et al., Nutritional deficiencies that may predispose to long COVID, Inflammopharmacology, doi:10.1007/s10787-023-01183-3.springer.com, doi.org.

23. Shah Alam et al., The role of vitamin D in reducing SARS-CoV-2 infection: An update, International Immunopharmacology, doi:10.1016/j.intimp.2021.107686.sciencedirect.com, doi.org.

24. Xu et al., The importance of vitamin d metabolism as a potential prophylactic, immunoregulatory and neuroprotective treatment for COVID-19, Journal of Translational Medicine, doi:10.1186/s12967-020-02488-5.biomedcentral.com, doi.org.

EFSA et al., 25 Feb 2010, peer-reviewed, 21 authors.

This Paper Vitamin D All

Scientific Opinion on the substantiation of health claims related to vitamin D and normal function of the immune system and inflammatory response (ID 154, 159), maintenance of normal muscle function (ID 155) and maintenance of normal cardiovascular function (ID 159) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, J J ) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik Van Loveren, Marina Heinonen, Hans Verhagen The, Maria Carmen Collado, Miguel Gueimonde, Daisy Jonkers, Maria Saarela

EFSA Journal, doi:10.2903/j.efsa.2010.1468

EFSA), Parma, Italy

INFORMATION AS PROVIDED IN THE CONSOLIDATED LIST The consolidated list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006 4 submitted by Member States contains main entry claims with corresponding conditions of use and literature from similar health claims. The information provided in the consolidated list for the health claims which are the subject of this opinion is tabulated in Appendix C. EFSA Journal 2010; 8(2):1468 A cause and effect relationship has not been established between the dietary intake of vitamin D and maintenance of normal cardiovascular function. Conditions and possible restrictions of use In order to bear the claims a food should be at least a source of vitamin D as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population. DOCUMENTATION PROVIDED TO EFSA Health claims pursuant to Article 13(1) of Regulation (EC) No 1924 /2006 (No: EFSA-Q-2008 -941, EFSA-Q-2008 -942, EFSA-Q-2008-946) . The scientific substantiation is based on the information provided by the Members States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The full list of supporting references as provided to EFSA is available on: http://www.efsa.europa.eu/panels/nda/claims/article13.htm APPENDICES APPENDIX A BACKGROUND AND TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN..

References

Armas, Hollis, Heaney, Vitamin D2 is less effective than vitamin D3 in humans, Journal of Clinical Endocrinology & Metabolism

Bikle, Nonclassic actions of vitamin D, Journal of Clinical Endocrinology & Metabolism

Cantorna, Bruce, The paradoxical effects of vitamin D on type 1 mediated immunity, Molecular Aspects of Medicine

Cedap, Avis de la commission interministérielle d'étude des produits destinés à une alimentation particulière (CEDAP) en date du 18 décembre 1996 sur les recommandations relatives au caractère non trompeur des seuils des allégations nutritionnelles fonctionnelles, BOCCRF (Bulletin Officiel de la Concurrence, de la Consommation et de la Répression des fraudes)

Ceglia, Vitamin D and skeletal muscle tissue and function, Molecular Aspects of Medicine

Cohen-Lahay, Douvdevani, Chaimovitz, Shany, The anti-inflammatory activity of 1,25-dihydroxyvitamin D3 in macrophages, Journal of Steroid Biochemistry and Molecular Biology

Cotler, Moreines, Ellenogen, Potential benefits for the use of vitamin and mineral supplements

Khazai, Tangpricha, Calcium and vitamin D: skeletal and extraskeletal health, Current Rheumatology Reports

Norman, Henry, Vitamin D, in Present Knowledge in Nutrition, Intl Life Sciences Inst

Odaious, Ordonnance du Conseil Fédéral Suisse du Mars 1995 sur le denrées alimentaires et les objets usuels

Patel, Farragher, Berry, Bunn, Sliman et al., Association between serum vitamin D metabolite levels and disease activity in patients with early inflammatory polyarthritis, Arthritis Rheumatisms

Schott, Wills, Opinion on the Tolerable Upper Intake Level of Vitamin D, Lancet

Shoji, Shinohara, Kimoto, Emoto, Tahara et al., Lower risk for cardiovascular mortality in oral 1αhydroxy vitamin D3 users in a haemodialysis population, Nephrology Dialysis Transplantation

Sorensen, Lund, Saltin, Andersen, Hjorth et al., Myopathy in bone loss of ageing: improvement by treatment with 1 alpha-hydroxycholecalciferol and calcium, Clinical Science

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