The Foundation for Medical Research, Mumbai, Maharashtra, India.
Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
BMJ Open. 2022 Aug 29;12(8):e061301. doi: 10.1136/bmjopen-2022-061301.
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.
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.
Ethical approval was obtained from institutional ethical committees of all participating institutions. The study findings will be presented in peer-reviewed medical journals.
NCT04641195, CTRI/2021/04/032593, HMSC (GOI)-2021-0060.
目前，除了疫苗等预防措施外，针对 SARS-CoV-2 感染几乎没有人群层面的策略。微量营养素缺乏，特别是维生素 D 和锌缺乏，与宿主反应失调有关，可能在 COVID-19 中发挥重要作用。
我们设计了一项 2×2 析因、随机、双盲、多中心安慰剂对照试验，以评估维生素 D 和锌对印度马哈拉施特拉邦 COVID-19 结局的影响。从孟买和浦那的医院招募 COVID-19 阳性个体。参与者接受（1）维生素 D3 冲击（180000IU），维持剂量为每天 2000IU 和/或（2）葡萄糖酸锌（每天 40mg），与安慰剂相比持续 8 周。参与者在基线和 8 周时进行详细评估，并在住院期间或离开医院后每 3 天进行一次监测，以评估症状和其他临床指标。在入组后 12 周进行最终随访电话，以评估长期结局。该研究的主要结局是恢复时间，定义为所有发热、咳嗽和呼吸急促症状缓解的时间。次要结局包括：住院时间、全因死亡率、需要辅助通气、血液生物标志物水平变化和个体症状持续时间。参与者招募于 2021 年 4 月开始。
所有参与机构的机构伦理委员会均批准了该研究。研究结果将在同行评议的医学期刊上发表。
NCT04641195、CTRI/2021/04/032593、HMSC（GOI）-2021-0060。
