Comparison · NCT03096314-sae
High Dose Vitamin D Formulation 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
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ConductScience Library. High Dose Vitamin D Formulation vs Placebo: serious adverse events. Trial comparisons, record NCT03096314-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03096314-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 | 0.0203 | 0.0121 | 0.0338 | wilson | |
| Risk in group 2 | 0.0269 | 0.0171 | 0.0422 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00666 | -0.0239 | 0.01 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.753 | 0.378 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 0.748 | 0.369 | 1.52 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on High Dose Vitamin D Formulation than on Placebo | 150 | 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 | High Dose Vitamin D Formulation | A single dose of 540,000 IU vitamin D3 will be administered within 2 hours of randomization time.~Vitamin D3: 540,000 IU vitamin D3 | 14 | 690 | EG000 |
| Group 2 | Placebo | A single, liquid enteral placebo dose administered either orally or via naso/orogastric tube will be administered within 2 hours of randomization time.~Placebo: A single, liquid enteral dose administered either orally or via naso/orogastric tube | 18 | 668 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Subjects were assessed for adverse events from enrollment (signing of the informed consent) through study day 14 or hospital discharge, whichever occurs first. Investigators will determine if the event is serious or related to the study drug. The rationale for this time window is the 2 week half-life of 25OHD, which helps to define the period at risk from vitamin D.
Source ClinicalTrials.gov
Trial
- Title
- Vitamin D to Improve Outcomes by Leveraging Early Treatment
- NCT number
- NCT03096314
- Phases
- PHASE3
- Conditions
- Acute Respiratory Distress Syndrome, Vitamin D Deficiency, Critical Illness
- Interventions
- Vitamin D3, Placebo
- Lead sponsor
- Massachusetts General Hospital
- Results first posted
- 2020-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03096314?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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