Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition

February 23, 2012 updated by: Dr Zulfiqar Ahmed Bhutta, Aga Khan University

Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition (SAM) Receiving Community-based Nutritional Rehabilitation Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives

  1. To assess energy expenditure and body composition by stable isotope techniques in children with Severe Acute Malnutrition
  2. To evaluate the potential usefulness of body composition assessment as a predictor of outcome in children with SAM, based on stable isotope technique and multi-frequency bioelectrical impedance analysis (BIA)

Inclusion criteria

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

Exclusion criteria

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
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
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
Active Comparator: Group 2
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

International Atomic Energy Agency

Investigators

  • Principal Investigator: Zulfiqar A Bhutta, MBBS,FCPS,FRCP,PhD, Aga Khan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Estimate)

February 27, 2012

Last Update Submitted That Met QC Criteria

February 23, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1400-Ped-ERC-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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