Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition

Wasting Clinical Trial

Official title:

Using Indigenous Foods to Reduce Malnutrition in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898871
• Other study ID #: CMR6010
• Status: Completed
• Phase: Phase 2
• First received: July 10, 2013
• Last updated: July 10, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Centre for Food and Nutrition Research, Yaounde
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Moderate Acute Malnutrition
• Wasting

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Cameroon	Evodoula Health District	Evodoula
Cameroon	Biyem Assi District Centre	Yaounde

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Food and Nutrition Research, Yaounde	International Atomic Energy Agency

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate of the children receiving CSB+ or RUSF	Children with Weight-for-Height Z-score > -2	56 days	No