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NCT01144806 Clinical Trial

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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01144806
Other study ID # 1400-Ped-ERC-09
Secondary ID
Status Completed
Phase N/A
First received June 15, 2010
Last updated February 23, 2012
Start date June 2010
Est. completion date August 2011

Study information
Verified date February 2012
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority PAKISTAN: Aga Khan University's Ethical Review Committee
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 3 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
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

Locations
Country Name City State
Pakistan Aga Khan Univeristy Karachi Sindh
Pakistan Aga Khan University Karachi Sindh

Sponsors (2)
Lead Sponsor Collaborator
Aga Khan University International Atomic Energy Agency

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body composition 12 weeks No
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