Comparison · NCT03096314-df72f2ef
High Dose Vitamin D Formulation vs Placebo: Number of Participants Who Developed (New) ARDS to Day 7
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: Number of Participants Who Developed (New) ARDS to Day 7. Trial comparisons, record NCT03096314-df72f2ef. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03096314-df72f2ef
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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 | 0.0487 | 0.0317 | 0.074 | wilson | |
| Risk in group 2 | 0.0413 | 0.0259 | 0.0651 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0074 | -0.0218 | 0.037 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 0.627 | 2.22 | log | |
| Odds ratio, group 1 over group 2 | 1.19 | 0.613 | 2.3 | log | |
| Number needed to treat, for one more participant with the outcome on High Dose Vitamin D Formulation than on Placebo | 135 | 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 | 20 | 411 | OG000 |
| 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 | 17 | 412 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Developed (New) ARDS to Day 7
- Description
Presence of ARDS determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio (i.e., imputed P/F ratio) and chest x-ray confirmation. PaO2 = partial pressure of arterial oxygen; FiO2 = percentage of inspired oxygen; SpO2 = peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. For participants with P/F \<300 or imputed P/F \<300, FiO2 ≥40%, and PEEP ≥5 cm H2O, we determined if hypoxemia was valid, acute, and not fully explained by congestive heart failure (CHF) or fluid overload. PEEP = positive end expiatory pressure.
- Time frame
- Up to 7 days after randomization
- Population
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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