Comparison · NCT01785680-sae
Integrated Protocol vs Current Protocol: 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. Integrated Protocol vs Current Protocol: serious adverse events. Trial comparisons, record NCT01785680-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01785680-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 | 0.00348 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00446 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.00446 | 0.00348 | 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 harm | from the risk difference interval | the two groups' risks are equal |
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 | Integrated Protocol | Integrated protocol for treatment of children with MAM and SAM in humanitarian emergencies has the potential to result in a more streamlined, cost-effective program, higher recovery, and higher program coverage, allowing easier access to malnourished children, thus curing more children of malnutrition and preventing its lifelong effects.~Integrated Protocol: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC\>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 m | 0 | 1,100 | EG000 |
| Group 2 | Current Protocol | These treatment arm is the standard care for moderate malnutrition. This includes a fortified cereal supplement treatment until the child reaches MUAC of above 12.5. Currently, MAM and SAM are treated separately, overseen by different agencies. Breastfeeding is often overlooked.~Current protocol: Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM. | 0 | 857 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone
- NCT number
- NCT01785680
- Phases
- NA
- Conditions
- Malnutrition
- Interventions
- Integrated Protocol, Current protocol
- Lead sponsor
- Washington University School of Medicine
- Results first posted
- 2020-03-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01785680?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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