PMID- 35322711 OWN - NLM STAT- MEDLINE DCOM- 20220816 LR - 20220902 IS - 0260-1060 (Print) IS - 2047-945X (Electronic) IS - 0260-1060 (Linking) VI - 28 IP - 3 DP - 2022 Sep TI - The effects of high dose vitamin D supplementation as a nutritional intervention strategy on biochemical and inflammatory factors in adults with COVID-19: Study protocol for a randomized controlled trial. PG - 311-317 LID - 10.1177/02601060221082384 [doi] AB - Introduction: Low serum vitamin D has been shown to be a risk factor for Coronavirus 2019 (COVID-19). The aim of this study was to assess the effects of high dose vitamin D supplementation on hs-CRP, ESR and clinical outcomes, including duration of hospitalization, quality of life and New York Heart Association (NYHA) Functional Classification, in adults with COVID-19. Methods: This double-blind, randomized control trial will be conducted on patients with RT-PCR and/or chest CT scan diagnosis of COVID-19 admitted in Imam Reza Hospital, Mashhad, Iran. Participants will be randomized into control and intervention groups based on randomization sampling. The intervention group will receive soft gel containing 50,000 IU vitamin D on the first day followed by 10,000 IU/day through a supplement drop daily for 29 days. The control group will receive 1000 IU vitamin D daily through supplement drop and a placebo soft gel. All participants will undergo laboratory assessment including inflammatory markers, serum 25)OH)D, complete blood count (CBC), liver and renal profile, lipid profile and erythrocyte sedimentation rate (ESR) at baseline and at day 30. The mortality rate will be recorded in both groups. Results: Data will be presented using descriptive statistics. Comparison of changes in study parameters over the study period will be performed using analysis of covariance adjusting for possible confounders. Conclusions: The findings of this will provide evidence on the effects of high dose vitamin D supplementation on inflammatory markers in hospitalized COVID-19 patients. FAU - Khorasanchi, Zahra AU - Khorasanchi Z AD - Department of Nutrition, School of Medicine, 37552Mashhad University of Medical Sciences, Mashhad, Iran. AD - Student Research Committee, Faculty of Medicine, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Jafazadeh Esfehani, Ali AU - Jafazadeh Esfehani A AD - Metabolic Syndrome Research Center, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Sharifan, Payam AU - Sharifan P AD - Department of Nutrition, School of Medicine, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Hasanzadeh, Elahe AU - Hasanzadeh E AD - International UNESCO center for Health Related Basic Sciences and Human Nutrition, Department of Nutrition, Faculty of Medicine, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Shadmand Foumani Moghadam, Mohammad Reza AU - Shadmand Foumani Moghadam MR AD - Varastegan Institute for Medical Sciences, Mashhad, Iran. FAU - Ahmadi, Omid AU - Ahmadi O AD - Department of Parasitology and Mycology, Torbat Jam Faculty of Medical Sciences, Torbat Jam, Iran. FAU - Ebrahimi, Reyhaneh AU - Ebrahimi R AD - International UNESCO center for Health Related Basic Sciences and Human Nutrition, Department of Nutrition, Faculty of Medicine, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Lotfi, Seyede Zahra AU - Lotfi SZ AD - Kidney Transplantation Complication Research Center, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Milani, Nasrin AU - Milani N AD - Department of Internal Medicine, Faculty of Medicine, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Mozdourian, Mahnaz AU - Mozdourian M AD - Lung Diseases Research Center, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Rezvani, Reza AU - Rezvani R AUID- ORCID: 0000-0003-3585-9854 AD - Department of Nutrition, School of Medicine, 37552Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Vatanparast, Hasan AU - Vatanparast H AUID- ORCID: 0000-0003-2621-8385 AD - College of Pharmacy and Nutrition, 7235University of Saskatchewan, Health Sciences E-Wing, Saskatoon, Saskatchewan, Canada. FAU - Assaran Darban, Reza AU - Assaran Darban R AD - Department of Biology, Faculty of Sciences, Mashhad Branch, Islamic Azad University, Mashhad, Iran. FAU - Ferns, Gordon AU - Ferns G AD - Division of Medical Education, Brighton and Sussex Medical School, Brighton, UK. FAU - Ghayour Mobarhan, Majid AU - Ghayour Mobarhan M AUID- ORCID: 0000-0002-1081-6754 AD - International UNESCO center for Health Related Basic Sciences and Human Nutrition, Department of Nutrition, Faculty of Medicine, 37552Mashhad University of Medical Sciences, Mashhad, Iran. LA - eng PT - Clinical Trial Protocol PT - Journal Article DEP - 20220324 PL - England TA - Nutr Health JT - Nutrition and health JID - 8306569 RN - 0 (Biomarkers) RN - 0 (Vitamins) RN - 1406-16-2 (Vitamin D) SB - IM MH - Adult MH - Biomarkers MH - *COVID-19 MH - Dietary Supplements MH - Humans MH - Quality of Life MH - Randomized Controlled Trials as Topic MH - Vitamin D MH - *Vitamin D Deficiency/drug therapy MH - Vitamins/therapeutic use PMC - PMC8948538 OTO - NOTNLM OT - COVID-19 OT - inflammation OT - vitamin d COIS- Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. EDAT- 2022/03/25 06:00 MHDA- 2022/08/17 06:00 PMCR- 2022/09/01 CRDT- 2022/03/24 08:39 PHST- 2022/03/25 06:00 [pubmed] PHST- 2022/08/17 06:00 [medline] PHST- 2022/03/24 08:39 [entrez] PHST- 2022/09/01 00:00 [pmc-release] AID - 10.1177_02601060221082384 [pii] AID - 10.1177/02601060221082384 [doi] PST - ppublish SO - Nutr Health. 2022 Sep;28(3):311-317. doi: 10.1177/02601060221082384. Epub 2022 Mar 24.