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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.
Sharma, Kamal Kant; Partap, Uttara; Mistry, Nerges; Marathe, Yogesh; Wang, Molin; Shaikh, Sanaa; D'Costa, Pradeep; Gupta, Gaurav; Bromage, Sabri; Hemler, Elena C; Kain, Kevin C; Dholakia, Yatin; Fawzi, Wafaie W.
  • Sharma KK; The Foundation for Medical Research, Mumbai, Maharashtra, India.
  • Partap U; Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Mistry N; The Foundation for Medical Research, Mumbai, Maharashtra, India.
  • Marathe Y; The Foundation for Medical Research, Mumbai, Maharashtra, India.
  • Wang M; Departments of Epidemiology and Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Shaikh S; The Foundation for Medical Research, Mumbai, Maharashtra, India.
  • D'Costa P; King Edward Memorial Hospital and Research Centre, Pune, Maharashtra, India.
  • Gupta G; Saifee Hospital, Mumbai, Maharashtra, India.
  • Bromage S; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Hemler EC; Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
  • Kain KC; Department of Medicine, University Health Network, Toronto, Ontario, Canada.
  • Dholakia Y; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
  • Fawzi WW; The Foundation for Medical Research, Mumbai, Maharashtra, India.
BMJ Open ; 12(8): e061301, 2022 08 29.
Статья в английский | MEDLINE | ID: covidwho-2020051
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.
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Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: COVID-19 Тип исследования: Когортное исследование / Экспериментальные исследования / Наблюдательное исследование / Прогностическое исследование / Рандомизированные контролируемые испытания Темы: Длинный Ковид / Традиционная медицина / Вакцина Пределы темы: Люди Страна как тема: Азия Язык: английский Журнал: BMJ Open Год: 2022 Тип: Статья Аффилированная страна: Bmjopen-2022-061301

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Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: COVID-19 Тип исследования: Когортное исследование / Экспериментальные исследования / Наблюдательное исследование / Прогностическое исследование / Рандомизированные контролируемые испытания Темы: Длинный Ковид / Традиционная медицина / Вакцина Пределы темы: Люди Страна как тема: Азия Язык: английский Журнал: BMJ Open Год: 2022 Тип: Статья Аффилированная страна: Bmjopen-2022-061301