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

NCT ID: NCT01154595

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Child Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Food-for-Training component

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.

Group Type ACTIVE_COMPARATOR

Food-for-Training

Intervention Type 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))

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.

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

47g Plumpy Doz(r) per day per child

Food-for-Training

Intervention Type 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.

Interventions

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

47g Plumpy Doz(r) per day per child

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

Action Contre la Faim

OTHER

Sponsor Role lead

Responsible Party

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Lieven Huybregts

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Kolsteren, PhD MD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Lieven Huybregts, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Action Contre La Faim Tchad

Abéché, , Chad

Site Status

Countries

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Chad

References

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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.

Reference Type DERIVED
PMID: 23028263 (View on PubMed)

Other Identifiers

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UGENT0410

Identifier Type: -

Identifier Source: org_study_id