{"doi":"10.1136/bmjopen-2022-061301","title":"Randomised trial to determine the effect of vitamin D and zinc supplementation for improving treatment outcomes among patients with COVID-19 in India: trial protocol","abstract":"INTRODUCTION: Presently, there are few population-level strategies to address SARS-CoV-2 infection except preventive measures such as vaccination. Micronutrient deficiency, particularly vitamin D and zinc deficiency, has been associated with dysregulated host responses, and may play an important role in COVID-19. METHODS AND ANALYSIS: We have designed a 2×2 factorial, randomised, double-blind, multi-centre placebo-controlled trial to evaluate the effect of vitamin D and zinc on COVID-19 outcomes in Maharashtra, India. COVID-19 positive individuals are recruited from hospitals in Mumbai and Pune. Participants are provided (1) vitamin D3 bolus (180 000 IU) maintained by daily dose of 2000 IU and/or (2) zinc gluconate (40 mg daily), versus placebo for 8 weeks. Participants undergo a detailed assessment at baseline and at 8 weeks, and are monitored daily in hospital or every 3 days after leaving the hospital to assess symptoms and other clinical measures. A final follow-up telephone call occurs 12 weeks post-enrolment to assess long-term outcomes. The primary outcome of the study is to time to recovery, defined as time to resolution of all of fever, cough and shortness of breath. Secondary outcomes include: duration of hospital stay, all-cause mortality, necessity of assisted ventilation, change in blood biomarker levels and individual symptoms duration. Participant recruitment commenced on April 2021. ETHICS AND DISSEMINATION: Ethical approval was obtained from institutional ethical committees of all participating institutions. The study findings will be presented in peer-reviewed medical journals. TRIAL REGISTRATION NUMBERS: NCT04641195, CTRI/2021/04/032593, HMSC (GOI)-2021-0060.","journal":"BMJ Open","year":2022,"id":276927,"datarank":0.480040922098531,"base_score":2.1972245773362196,"endowment":2.1972245773362196,"self_citation_contribution":0.32958368660043297,"citation_network_contribution":0.15045723549809803,"self_endowment_contribution":0.32958368660043297,"citer_contribution":0.15045723549809803,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":6,"citers_with_citation_signal":5,"citers_with_endowment":5,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9147,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04641195"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":947903,"name":"Uttara Partap","orcid":"0000-0002-2531-1804","position":1,"is_corresponding":false},{"id":813654,"name":"Nerges Mistry","orcid":"0000-0003-3509-4994","position":2,"is_corresponding":false},{"id":948519,"name":"Yogesh N. Marathe","orcid":null,"position":3,"is_corresponding":false},{"id":131778,"name":"Molin Wang","orcid":"0000-0003-1951-8961","position":4,"is_corresponding":false},{"id":948520,"name":"Sanaa Shaikh","orcid":null,"position":5,"is_corresponding":false},{"id":948521,"name":"Pradeep D’costa","orcid":null,"position":6,"is_corresponding":false},{"id":775950,"name":"Gaurav Gupta","orcid":"0000-0001-7941-0229","position":7,"is_corresponding":false},{"id":615426,"name":"Sabri Bromage","orcid":"0000-0002-6552-4871","position":8,"is_corresponding":false},{"id":712036,"name":"Elena C. Hemler","orcid":"0000-0001-6986-9474","position":9,"is_corresponding":false},{"id":493451,"name":"Kevin C. Kain","orcid":"0000-0001-6068-1272","position":10,"is_corresponding":false},{"id":947904,"name":"Yatin Dholakia","orcid":"0000-0001-8482-1305","position":11,"is_corresponding":false},{"id":293107,"name":"Wafaie Fawzi","orcid":"0000-0002-2908-600X","position":12,"is_corresponding":false},{"id":947902,"name":"Kamal Kant Sharma","orcid":"0000-0001-9204-3056","position":0,"is_corresponding":true}],"reference_count":49,"raw_metadata":null,"created_at":"2026-07-19T00:28:34.768552Z","pmid":"36038172","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}