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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01144806
First Posted: June 16, 2010
Last Update Posted: February 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
International Atomic Energy Agency
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University
  Purpose
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

Condition Intervention
Children Malnutrition Behavioral: Nutrition education Dietary Supplement: RUTF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition (SAM) Receiving Community-based Nutritional Rehabilitation Therapy

Resource links provided by NLM:


Further study details as provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:

Primary Outcome Measures:
  • Body composition [ Time Frame: 12 weeks ]

Enrollment: 60
Study Start Date: June 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144806


Locations
Pakistan
Aga Khan Univeristy
Karachi, Sindh, Pakistan, 74800
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
International Atomic Energy Agency
Investigators
Principal Investigator: Zulfiqar A Bhutta, MBBS,FCPS,FRCP,PhD Aga Khan University
  More Information

Responsible Party: Dr Zulfiqar Ahmed Bhutta, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT01144806     History of Changes
Other Study ID Numbers: 1400-Ped-ERC-09
First Submitted: June 15, 2010
First Posted: June 16, 2010
Last Update Posted: February 27, 2012
Last Verified: February 2012

Keywords provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:
SAM
RUTF
BIA
D2O
Children with severe malnutrition

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Nutrition Disorders