Vitamin D and Zinc Supplementation to Improve Treatment Outcomes among COVID-19 Patients in India: Results from a Double-Blind Randomized Placebo-Controlled Trial
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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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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it