Clinical trial NCT01724073: Regular Consumption of Leafy Vegetable Sauces and Micro-nutrient Status of Young Children in Burkina Faso
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anemia
Keywords: food to food fortification strategy
leafy vegetable
iron
zinc
vitamin A
growth
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: IRSAT DTA Burkina Faso
name: Hopital Yalgado Ouedraogo Burkina Faso
First posted: 2012-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age between 12 and 15 months
* signed informed consent by parent or caregiver
* accept to eat every ingredient used for the preparation of the sauces

Exclusion Criteria:

* any chronic illness affecting growth or iron status (thalassemia or sickle-cell anemia) no informed consent
* severe acute malnutrition which will require direct treatment
* severe anemia which will require direct treatment

Primary outcomes:
measure: Change in micronutrient status
timeFrame: six months
measure: Growth
timeFrame: 6 months
Secondary outcomes:
measure: food consumption
timeFrame: at t=around 1 month
measure: Intake of experimental food
timeFrame: up to 6 months
measure: Morbidity
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Institut de Recherche en Sciences Aplliquées et Technologie - DTA
state: Centre
Study officials:
affiliation: Institut de Recherche pour le Developpement
name: Claire Mouquet-Rivier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Recherche en Sciences Aplliquées et Technologie - DTA
name: Bréhima Diawara, PhD
role: PRINCIPAL_INVESTIGATOR
References: