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Regular Consumption of Leafy Vegetable Sauces and Micro-nutrient Status of Young Children in Burkina Faso

NCT01724073 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-03-05

No results posted yet for this study

Summary

A food-to-food fortification strategy has been designed based on traditional foods of Burkina Faso to fight against micronutrient deficiencies in young children. Leafy vegetable sauces were formulated to improve their micronutrient contents and bioavailability. This efficacy study was designed to assess the effects of the regular consumption (one meal per day, 6 days per week) of these leafy-vegetable sauces enriched or not with liver on iron, zinc and vitamin A status, growth and morbidity of young children from poor urban districts of Ouagadougou. The study is conducted by IRD and IRSAT-DTA and will last 6 months. 432 12-15 month-old children will be recruited and randomly assigned to one of the four following arms: three intervention groups, the two first receiving leafy vegetable sauce, the third one receiving one meal made of the fortified Misola gruel. In these three arms, blood samples will be collected at the beginning and at the end of the study. The fourth arm is an external control group and will not receive any food. In this fourth arm, blood samples will be collected only at the end of the study. Biochemical indicators of micronutrient status will be determined, and anthropometric data will be collected in all children. Morbidity will also be assessed in children of intervention groups.

Conditions

Interventions

DIETARY_SUPPLEMENT

Leafy vegetable-fish sauce

DIETARY_SUPPLEMENT

Leafy vegetable-fish/liver sauce

DIETARY_SUPPLEMENT

Misola

Sponsors & Collaborators

  • IRSAT DTA Burkina Faso

    collaborator UNKNOWN

  • Hopital Yalgado Ouedraogo Burkina Faso

    collaborator UNKNOWN

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Claire Mouquet-Rivier, PhD · Institut de Recherche pour le Developpement

  • Bréhima Diawara, PhD · Institut de Recherche en Sciences Aplliquées et Technologie - DTA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-05-31
Completion
2013-08-31

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01724073 on ClinicalTrials.gov