Comparison · NCT00395161-sae
Daily Nutriceutical Supplementation vs Whey Protein: 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. Daily Nutriceutical Supplementation vs Whey Protein: serious adverse events. Trial comparisons, record NCT00395161-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00395161-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 | 0.493 | 0.414 | 0.573 | wilson | |
| Risk in group 2 | 0.504 | 0.422 | 0.585 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0104 | -0.124 | 0.104 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.979 | 0.777 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 0.959 | 0.604 | 1.52 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Daily Nutriceutical Supplementation than on Whey Protein | 96.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Daily Nutriceutical Supplementation | Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs. | 73 | 148 | EG000 |
| Group 2 | Whey Protein | Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs. | 70 | 139 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected for 28 days.
Source ClinicalTrials.gov
Trial
- Title
- The CRISIS Prevention Study
- NCT number
- NCT00395161
- Phases
- PHASE3
- Conditions
- Sepsis
- Interventions
- Metoclopramide, Zinc, Glutamine, Selenium, saline, sterile water, selenium, whey-protein
- Lead sponsor
- Michael Dean
- Results first posted
- 2013-04-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00395161?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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