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

Malnutrition Clinical Trial

— PREAMA  

Official title:

Effectiveness and Cost-effectiveness of a Ready-to-Use-Food (RUF) Supplement to Prevent Acute Malnutrition in Children Between 6-36 Months in Urban Chad

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154595
• Other study ID #: UGENT0410
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2010
• Last updated: October 10, 2011
• Start date: June 2010
• Est. completion date: February 2011

Study information

• Verified date: October 2011
• Source: Action Contre la Faim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chad: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child
• Malnutrition

Intervention

Dietary Supplement:
• Plumpy Doz(r) - Ready-to-Use Food
47g Plumpy Doz(r) per day per child

Behavioral:
• 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.

Locations

Country	Name	City	State
Chad	Action Contre La Faim Tchad	Abéché

Sponsors (2)

Lead Sponsor	Collaborator
Action Contre la Faim	University Ghent

Country where clinical trial is conducted

Chad, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative wasting incidence, hemoglobin concentration		monthly	No
Secondary	weight gain		monthly	No
Secondary	time to become wasted		monthly	No
Secondary	default rate		monthly	No
Secondary	RUF acceptability		monthly	No
Secondary	dietary intake		monthly	No