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Completed

NCT Number: NCT01154595

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

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.

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Key information

Conditions

Child Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Action Contre La Faim Tchad

Abéché, Chad

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary Supplement

47g Plumpy Doz(r) per day per child

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.

Primary outcomes

  1. Cumulative wasting incidence, hemoglobin concentration

    Time frame: monthly

Secondary outcomes

  1. weight gain

    Time frame: monthly

  2. time to become wasted

    Time frame: monthly

  3. default rate

    Time frame: monthly

  4. RUF acceptability

    Time frame: monthly

  5. dietary intake

    Time frame: monthly

Sponsors and collaborators

Lead sponsor

Action Contre la Faim

Other

Collaborators

  • University Ghent

Registry information

Official study 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

Acronym: PREAMA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2010
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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