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

Action Against Hunger

Status and phase: Completed; Phase 4

Conditions: Malnutrition; Child

Treatments: Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food; Behavioral: Food-for-Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01154595

UGENT0410

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2,000 participants in 2 patient groups

Food-for-Training component

Active Comparator group

Description:

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.

Treatment:

Behavioral: Food-for-Training

Food-for-Training + RUF (Plumpy Doz(r))

Experimental group

Description:

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.

Treatment:

Behavioral: Food-for-Training

Dietary Supplement: Plumpy Doz(r) - Ready-to-Use Food