Vitamin D and Zinc Supplementation to Improve Treatment Outcomes among COVID-19 Patients in India: Results from a Double-Blind Randomized Placebo-Controlled Trial
Bibliographic record
Abstract
There remains a need to identify low-cost interventions to improve COVID-19 outcomes. Vitamin D and zinc play a role in respiratory infections, and could hold value as part of therapeutic regimens. To determine the effect of vitamin D or zinc supplementation on recovery from COVID-19. We conducted a double-blind randomized 2x2 factorial placebo-controlled trial with 1:1:1:1 allocation ratio, enrolling non-pregnant adults with COVID-19 from hospitals in Mumbai and Pune, India (NCT04641195). Participants (N=181) were randomized to vitamin D3 (180,000IU bolus, then 2000IU daily), zinc (40mg daily), vitamin D3 and zinc, or placebo, for 8 weeks. Participants were followed until 8 weeks. The primary outcome was time to resolution of fever, cough, and shortness of breath. Secondary outcomes were duration of individual symptoms; need for assisted ventilation; duration of hospital stay; all-cause mortality; and blood biomarkers including nutritional, inflammatory and immunological markers. We observed no effect of vitamin D or zinc supplementation on time to resolution of all three symptoms (vitamin D hazard ratio [HR]: 0.92, 95% confidence interval [95% CI]: 0.66-1.30, P=0.650; zinc HR: 0.94, 95% CI: 0.67-1.33, P=0.745). Neither vitamin D nor zinc supplementation was associated with secondary outcomes, except for increased endline serum vitamin D with vitamin D supplementation (median [interquartile range] difference between endline and baseline for vitamin D: 5.3ng/mL [-2.3-13.7]; for no vitamin D: -1.4ng/mL [-5.6-3.9]; P=0.003). We observed non-significant increases in serum zinc at endline following zinc supplementation. There was no evidence of interaction between vitamin D and zinc supplementation; no effect of either on hypercalcemia; and no adverse events. Results suggest that neither vitamin D nor zinc supplementation improve COVID-19 treatment outcomes in this population. However, much larger-scale evidence, particularly from populations with vitamin D or zinc deficiency and severe infection, is required to corroborate our findings. NCT04641195, CTRI/2021/04/032593.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".