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Trial · NCT01785680

Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone

NCT01785680, Not applicable, Completed, Washington University School of Medicine; results first posted 2020-03-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone. Trials, record NCT01785680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01785680

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) in Sierra Leone
NCT number
NCT01785680
Status
Completed
Phases
Not applicable
Enrollment
1,957 participants, actual
Lead sponsor
Washington University School of Medicine
Conditions
Malnutrition
Interventions
Integrated Protocol, Current protocol
First posted
2013-02-07
Last updated
2020-03-26
Results first posted
2020-03-26

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRecovery Under the Integrated Program and the Standard Protocol12 weeks
Recovery by the end of treatment standard protocol will be compared to the integrated protocol. Recovery will be defined as mid upper arm circumference (MUAC) reaching ≥12.5 cm. Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed.
SecondaryChange in Growth Rates12 weeksSubjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Measurement is taken at each visit but final recovery measurement will be used.
SecondaryDuration of Treatment12 weeksSubjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Time to achieve MUAC of 12.5 cm will be documented.
SecondaryChange in Recovery Status After 12 Weeks6 monthsAny changes in recovery will be measured 6 months at follow-up visit. Number of children still well nourished.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYRecovery Under the Integrated Program and the Standard Protocol12 weeksRecovery was defined as mid upper arm circumference ≥12.5 cm.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange in Growth Rates12 weekscmMEAN
SECONDARYDuration of Treatment12 weeksNumber of clinic visitsMEAN
SECONDARYChange in Recovery Status After 12 Weeks6 monthsParticipantsCOUNT_OF_PARTICIPANTS

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Recovery Under the Integrated Program and the Standard ProtocolIntegrated Protocol910Participants
Recovery Under the Integrated Program and the Standard ProtocolCurrent Protocol682Participants
Change in Growth RatesIntegrated Protocol0.52Standard Deviation 0.04cm
Change in Growth RatesCurrent Protocol0.25Standard Deviation 0.02cm
Duration of TreatmentIntegrated Protocol2.7Standard Deviation 0.06Number of clinic visits
Duration of TreatmentCurrent Protocol3.5Standard Deviation 0.07Number of clinic visits
Change in Recovery Status After 12 WeeksIntegrated Protocol544Participants
Change in Recovery Status After 12 WeeksCurrent Protocol459Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDIntegrated Protocol1,100
Overall StudySTARTEDCurrent Protocol857
Overall StudyCOMPLETEDIntegrated Protocol1,100
Overall StudyCOMPLETEDCurrent Protocol857
Overall StudyNOT COMPLETEDIntegrated Protocol0
Overall StudyNOT COMPLETEDCurrent Protocol0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityIntegrated Protocol421,100
Total, all-cause mortalityCurrent Protocol35857
Total, other adverse eventsIntegrated Protocol01,100
Total, other adverse eventsCurrent Protocol0857
Total, serious adverse eventsIntegrated Protocol01,100
Total, serious adverse eventsCurrent Protocol0857

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
17076211BACKGROUNDPubMed
17585038BACKGROUNDPubMed
18614728BACKGROUNDPubMed
20332221BACKGROUNDPubMed
20980648BACKGROUNDPubMed
22170366BACKGROUNDPubMed
26423737RESULTPubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U01GH000647INTEGRATED PROTOCOL FOR TREATMENT OF MAM AND SAM IN HUMANITARIAN EMERGENCIESMANARY, MARK JOHNWASHINGTON UNIVERSITYCenter for Global Health2012 to 2013

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Integrated Protocol vs Current Protocol: Recovery Under the Integrated Program and the Standard ProtocolTrial comparisons
Integrated Protocol vs Current Protocol: Change in Recovery Status After 12 WeeksTrial comparisons
Integrated Protocol vs Current Protocol: deaths from any causeTrial comparisons
Integrated Protocol vs Current Protocol: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
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
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01785680

GET https://conductscience.org/api/trials/v1/NCT01785680/registered