Regular Consumption of Leafy Vegetable Sauces and Micro-nutrient Status of Young Children in Burkina Faso (Instapa-WP4)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01724073|
Recruitment Status : Withdrawn (Approval denied by national ethical committee of Burkina Faso)
First Posted : November 9, 2012
Last Update Posted : March 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Dietary Supplement: Leafy vegetable-fish sauce Dietary Supplement: Leafy vegetable-fish/liver sauce Dietary Supplement: Misola||Not Applicable|
Micronutrient deficiencies and stunting are a major health concern in young children of many developing countries, including Burkina Faso. This poor nutritional status affects health, with a much higher risk for mortality, and delayed physical and cognitive development.
The INSTAPA project focuses on the improvement of millet-, sorghum-, maize-, and cassava-based foods for young children in sub-Saharan Africa to safely prevent deficiencies of iron, zinc, and vitamin A.
Food-to-food fortification strategy has rarely been tested in efficacy studies, despite its promising sustainability. The study will be conducted by IRD, IRSAT-DTA, with funding of the European Union.
Subjects of the study, 12-15 month old burkinabè children will be divided into 4 arms. 108 children per group (432, in all) will be recruited in order to have 90 children in each group after exclusion due severe anemia or hemoglobinopathy. Each enrolled child will be dewormed according to WHO recommendations, and receive a bed-net for malaria prevention.
Three of these four groups will receive one test meal per day, 6 days per week (except Sunday)in canteens located in study districts. Investigators will record every day the amount of food consumed and morbidity in each child.
- one intervention group receiving leafy vegetable-fish sauce + cereal-based paste called tô,
- one intervention group receiving leafy vegetable-fish sauce + cereal-based paste called tô 5 days/week and leafy vegetable-fish sauce + tô 1 day/week,
- one 'positive control' group receiving a fortified gruel prepared from Misola Flour 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 iron, zinc and vitamin A status will be determined, and anthropometric data will be collected in all children.
The study is submitted to the Ethical committee of the Ministry of Health of Burkina Faso and to the review board of the local drug administration (DGPML) for approval, as well as to the Ethical committee of IRD (France).
According to the results, recommendations on the young child diet will be formulated for the attention of the staff of health facilities and families.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of the Regular Consumption of Leafy-vegetable Sauces, Rich in Iron, Zinc and Vitamin A, on Growth and Micro-nutrient Status of Young Children in Burkina Faso|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||August 2013|
Experimental: Leafy vegetable-fish sauce
one meal per day, 6 days a week, with leafy vegetable-fish sauce + tô, a local cereal-based paste
Dietary Supplement: Leafy vegetable-fish sauce
Experimental: Leafy vegetable-fish/liver sauce
one meal per day, 6 days a week, 5 days with leafy vegetable-fish sauce + tô, 1 day with leafy vegetable-liver sauce + tô
Dietary Supplement: Leafy vegetable-fish/liver sauce
one meal per day, 6 days a week, with gruel prepared with the fortified Misola flour
Dietary Supplement: Misola
No Intervention: no test food
control group receiving no test food
- Change in micronutrient status [ Time Frame: six months ]iron, zinc and vitamin A status using plasma concentrations
- Growth [ Time Frame: 6 months ]Weight, length, mid-upper arm circumference
- food consumption [ Time Frame: at t=around 1 month ]weighed record during one whole day
- Intake of experimental food [ Time Frame: up to 6 months ]the amount of experimental food eaten by each child will be weighed every day
- Morbidity [ Time Frame: up to 6 months ]daily record by questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724073
|Institut de Recherche en Sciences Aplliquées et Technologie - DTA|
|Ouagadougou, Centre, Burkina Faso|
|Principal Investigator:||Claire Mouquet-Rivier, PhD||Institut de Recherche pour le Developpement|
|Principal Investigator:||Bréhima Diawara, PhD||Institut de Recherche en Sciences Aplliquées et Technologie - DTA|