Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition

NCT ID: NCT01898871

Last Updated: 2013-07-12

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

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children.

Detailed Description

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Assuming the availability of some food in the household, the caregivers were instructed on how best to use the food they have and the quantity of supplementary food distributed was calculated to provide about 50% of child energy requirement.

Conditions

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Wasting Moderate Acute Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ready to Use Suplementary Food (RUSF)

A daily ration of 40 kcal/kg of body weight during 56 days

Group Type EXPERIMENTAL

A daily ration of 40 kcal/kg of body weight during 56 days

Intervention Type DIETARY_SUPPLEMENT

On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.

Corn Soya Blend (CSB+)

A daily ration of 40 kcal/kg of body weight during 56 days

Group Type ACTIVE_COMPARATOR

A daily ration of 40 kcal/kg of body weight during 56 days

Intervention Type DIETARY_SUPPLEMENT

On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.

Interventions

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A daily ration of 40 kcal/kg of body weight during 56 days

On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Children aged 6-59 month
* Weight-for-height between -3 and -2 z-scores without edema
* Good appetite
* Stable clinical conditions

Exclusion Criteria

* Weight-for-Height Z-score \< -3
* Presence of bilateral pitting edema
* Unstable clinical conditions
* Not showing appetite
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Atomic Energy Agency

OTHER_GOV

Sponsor Role collaborator

Centre for Food and Nutrition Research, Yaounde

OTHER_GOV

Sponsor Role lead

Responsible Party

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Medoua Nama Gabriel

Deputy Head of Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriel Medoua Nama, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre for Food and Nutrition Research, IMPM

Locations

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Evodoula Health District

Évodoula, , Cameroon

Site Status

Biyem Assi District Centre

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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CMR6010

Identifier Type: -

Identifier Source: org_study_id

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