Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition
Primary Purpose
Children, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Nutrition education
RUTF
Sponsored by
About this trial
This is an interventional treatment trial for Children focused on measuring SAM, RUTF, BIA, D2O, Children with severe malnutrition
Eligibility 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
Sites / Locations
- Aga Khan Univeristy
- Aga Khan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
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
Ready to use therapeutic food (RUTF / PlumpyNut)will be provided to parent/care givers of children with severe malnutrition in enrolled in this group
Outcomes
Primary Outcome Measures
Body composition
Secondary Outcome Measures
Full Information
NCT ID
NCT01144806
First Posted
June 15, 2010
Last Updated
February 23, 2012
Sponsor
Aga Khan University
Collaborators
International Atomic Energy Agency
1. Study Identification
Unique Protocol Identification Number
NCT01144806
Brief Title
Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition
Official Title
Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition (SAM) Receiving Community-based Nutritional Rehabilitation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
International Atomic Energy Agency
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Objectives
To assess energy expenditure and body composition by stable isotope techniques in children with Severe Acute Malnutrition
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Malnutrition
Keywords
SAM, RUTF, BIA, D2O, Children with severe malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Ready to use therapeutic food (RUTF / PlumpyNut)will be provided to parent/care givers of children with severe malnutrition in enrolled in this group
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
RUTF
Intervention Description
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
Primary Outcome Measure Information:
Title
Body composition
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zulfiqar A Bhutta, MBBS,FCPS,FRCP,PhD
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan Univeristy
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition
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