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

NCT01154595 | Completed Phase 4 DMC

• 1 other identifier: UGENT0410
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Child; Malnutrition

Keywords

moderate acute malnutrition, prevention, Lipid-based supplement

Outcome Measures

Primary Outcomes (1)

• Cumulative wasting incidence, hemoglobin concentration

  monthly

Secondary Outcomes (5)

• weight gain

  monthly

• time to become wasted

  monthly

• default rate

  monthly

• RUF acceptability

  monthly

• dietary intake

  monthly

Study Arms (2)

Food-for-Training component

ACTIVE COMPARATOR

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.

Behavioral: Food-for-Training

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

EXPERIMENTAL

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.

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

Interventions

Plumpy Doz(r) - Ready-to-Use Food DIETARY_SUPPLEMENT

47g Plumpy Doz(r) per day per child

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

Food-for-Training BEHAVIORAL

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)); Food-for-Training component

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Action Contre la Faim: lead
• University Ghent: collaborator

Study Sites (1)

Action Contre La Faim Tchad

Abéché, Chad

Location

Related Publications (1)

• Huybregts L, Houngbe F, Salpeteur C, Brown R, Roberfroid D, Ait-Aissa M, Kolsteren P. The effect of adding ready-to-use supplementary food to a general food distribution on child nutritional status and morbidity: a cluster-randomized controlled trial. PLoS Med. 2012;9(9):e1001313. doi: 10.1371/journal.pmed.1001313. Epub 2012 Sep 18.

  PMID: 23028263 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Patrick Kolsteren, PhD MD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Lieven Huybregts, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

CH (1)