NCT01144806

Brief Summary

This project is being conducted with an aim to find out energy expenditure, body composition and recovery rates in children with severe acute malnutrition (SAM) receiving community-based nutritional rehabilitation therapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

1.2 years

First QC Date

June 15, 2010

Last Update Submit

February 23, 2012

Conditions

Keywords

SAMRUTFBIAD2OChildren with severe malnutrition

Outcome Measures

Primary Outcomes (1)

  • Body composition

    12 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Parent/care givers of children with severe malnutrition in enrolled in this group will be given nutrition education using the principles of infant and young child feeding (IYCF) and dietary diversification

Behavioral: Nutrition education

Group 2

ACTIVE COMPARATOR

Ready to use therapeutic food (RUTF / PlumpyNut)will be provided to parent/care givers of children with severe malnutrition in enrolled in this group

Dietary Supplement: RUTF

Interventions

Parent/care givers of children with severe malnutrition in enrolled in this group will be given nutrition education using the principles of infant and young child feeding (IYCF) and dietary diversification

Group 1
RUTFDIETARY_SUPPLEMENT

Ready to use therapeutic food (RUTF / PlumpyNut) will be provided to the parent/care givers of children with severe malnutrition in enrolled in this group

Group 2

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents of children of age 6 months to 3 years
  • Resident of study area

You may not qualify if:

  • Children with congenital malformations
  • Chronic debilitating illnesses
  • Refusal by parents to enroll in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aga Khan Univeristy

Karachi, Sindh, 74800, Pakistan

Location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Zulfiqar A Bhutta, MBBS,FCPS,FRCP,PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 16, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations