Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition

• Sponsor: Centre for Food and Nutrition Research, Yaounde (Other)
• Overall Status: Completed
• CT.gov ID: NCT01898871
• Collaborator: International Atomic Energy Agency (Other)
• Enrollment: 81
• Locations: 2
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 40.5
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Wasting; Moderate Acute Malnutrition	Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 days	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Using Indigenous Foods to Reduce Malnutrition in Children
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ready to Use Suplementary Food (RUSF) A daily ration of 40 kcal/kg of body weight during 56 days	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.
Active Comparator: Corn Soya Blend (CSB+) A daily ration of 40 kcal/kg of body weight during 56 days	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.

Outcome Measures

Primary Outcome Measures

1. Recovery rate of the children receiving CSB+ or RUSF [56 days]

   Children with Weight-for-Height Z-score > -2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 59 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evodoula Health District	Evodoula		Cameroon
2	Biyem Assi District Centre	Yaounde		Cameroon

Sponsors and Collaborators

• Centre for Food and Nutrition Research, Yaounde
• International Atomic Energy Agency

Investigators

• Principal Investigator: Gabriel Medoua Nama, Ph.D., Centre for Food and Nutrition Research, IMPM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medoua Nama Gabriel, Deputy Head of Centre, Centre for Food and Nutrition Research, Yaounde
• ClinicalTrials.gov Identifier: NCT01898871
• Other Study ID Numbers: CMR6010
• First Posted: Jul 12, 2013
• Last Update Posted: Jul 12, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Malnutrition

Study Results

No Results Posted as of Jul 12, 2013