Effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Child Malnutrition

Phase 4

Completed

• Conditions: Child; Malnutrition
• Interventions: Behavioral: Food-for-Training; Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food

• Registration Number: NCT01154595
• Lead Sponsor: Action Contre la Faim

Brief Summary

The overall objective of this project is to assess the effectiveness and cost-effectiveness of RUF (ready-to-Use Food, Plumpy Doz(r)) to prevent moderate acute malnutrition in children aged 6-36 months if embedded in a program of conditional household food assistance.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• WH≥80% of median of NCHS reference without bilateral pitting oedema;
• Age ≥ 6 months and ≤36 months;
• Member of a household with a dependency ratio >4;
• Not planning to leave the study zone for the coming 5 months;

Exclusion Criteria

• Not showing appetite;
• Age < 6 months or age > 36 months
• Weight-for-Height Z-score <-2 and/or the presence of bilateral pitting oedema in children 6-36 months;
• Member of a household with a dependency ration ≤ 4;
• Clinical complications
• Presence of chronic illness, cardiac disease, congenital abnormalities, cancer;
• Being allergic to one of the ingredients of the RUF.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food-for-Training component	Food-for-Training	Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.
Food-for-Training + RUF (Plumpy Doz(r))	Plumpy Doz(r) - Ready-to-Use Food	Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children. In addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided.
Food-for-Training + RUF (Plumpy Doz(r))	Food-for-Training	Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children. In addition, a blanket supplementation with 47g RUF (Plumpy Doz(r)) per day per child is provided.

Primary Outcome Measures

Name	Time	Method
Cumulative wasting incidence, hemoglobin concentration	monthly

Secondary Outcome Measures

Name	Time	Method
weight gain	monthly
time to become wasted	monthly
default rate	monthly
RUF acceptability	monthly
dietary intake	monthly

Trial Locations

Locations (1)

Action Contre La Faim Tchad; 🇹🇩 Abéché, Chad