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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01724073
Acronym
Instapa-WP4
Enrollment
0
Registered
2012-11-09
Start date
2012-12-31
Completion date
2013-08-31
Last updated
2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

food to food fortification strategy, leafy vegetable, iron, zinc, vitamin A, growth

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.

Interventions

DIETARY_SUPPLEMENTLeafy vegetable-fish sauce
DIETARY_SUPPLEMENTLeafy vegetable-fish/liver sauce
DIETARY_SUPPLEMENTMisola

Sponsors

IRSAT DTA Burkina Faso
CollaboratorUNKNOWN
Hopital Yalgado Ouedraogo Burkina Faso
CollaboratorUNKNOWN
Institut de Recherche pour le Developpement
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in micronutrient statussix monthsiron, zinc and vitamin A status using plasma concentrations
Growth6 monthsWeight, length, mid-upper arm circumference

Secondary

MeasureTime frameDescription
food consumptionat t=around 1 monthweighed record during one whole day
Intake of experimental foodup to 6 monthsthe amount of experimental food eaten by each child will be weighed every day
Morbidityup to 6 monthsdaily record by questionnaire

Countries

Burkina Faso

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026