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

NCT ID: NCT01144806

Last Updated: 2012-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-08-31

Brief Summary

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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

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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

Conditions

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Children Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Nutrition education

Intervention Type BEHAVIORAL

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 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

Group Type ACTIVE_COMPARATOR

RUTF

Intervention Type DIETARY_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

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Atomic Energy Agency

OTHER_GOV

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Dr Zulfiqar Ahmed Bhutta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zulfiqar A Bhutta, MBBS,FCPS,FRCP,PhD

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Aga Khan Univeristy

Karachi, Sindh, Pakistan

Site Status

Aga Khan University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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1400-Ped-ERC-09

Identifier Type: -

Identifier Source: org_study_id

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