Comparison · NCT02802449-sae
25 Hydroxy-Vitamin D3 or [25 (OH) D3] vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 25 Hydroxy-Vitamin D3 or [25 (OH) D3] vs Placebo: serious adverse events. Trial comparisons, record NCT02802449-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02802449-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.0172 | wilson | |
| Risk in group 2 | 0.00901 | 0.00159 | 0.0493 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00901 | -0.0493 | 0.00976 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on 25 Hydroxy-Vitamin D3 or [25 (OH) D3] than on Placebo | 111 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] | The participant will be randomized then given two 50,000 IU tablets of oral Vitamin D3 \[also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3\] to take under direct observation at the baseline and week 2 visit.~25 Hydroxy- Vitamin D3 \[25 (OH) D3\]: Two 50,000 IU tablets of oral Vitamin D3 \[also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3\] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator. | 0 | 219 | EG001 |
| Group 2 | Placebo | The participant will be randomized then given two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.~Placebo | 1 | 111 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected throughout duration of study = 12 weeks.
Source ClinicalTrials.gov
Trial
- Title
- To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans
- NCT number
- NCT02802449
- Phases
- NA
- Conditions
- Hypovitaminosis D
- Interventions
- 25 Hydroxy- Vitamin D3 [25 (OH) D3], Placebo
- Lead sponsor
- Charles Drew University of Medicine and Science
- Results first posted
- 2018-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02802449?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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