Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
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.
