Regular Consumption of Leafy Vegetable Sauces and Micro-nutrient Status of Young Children in Burkina Faso (Instapa-WP4)

Study Description

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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.

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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
Experimental: Misola; 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

Outcome Measures

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Primary Outcome Measures :

1. Change in micronutrient status [ Time Frame: six months ]
   iron, zinc and vitamin A status using plasma concentrations
2. Growth [ Time Frame: 6 months ]
   Weight, length, mid-upper arm circumference

Secondary Outcome Measures :

1. food consumption [ Time Frame: at t=around 1 month ]
   weighed record during one whole day
2. Intake of experimental food [ Time Frame: up to 6 months ]
   the amount of experimental food eaten by each child will be weighed every day
3. Morbidity [ Time Frame: up to 6 months ]
   daily record by questionnaire

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Months to 15 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Burkina Faso
Institut de Recherche en Sciences Aplliquées et Technologie - DTA
Ouagadougou, Centre, Burkina Faso

Sponsors and Collaborators

Institut de Recherche pour le Developpement

IRSAT DTA Burkina Faso

Hopital Yalgado Ouedraogo Burkina Faso

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

The INSTAPA project receives funding from the European Union's Seventh Framework Programme [FP7/2007-2013] under grant agreement no 211484 

website of the research unit of the principal investigator 

Responsible Party:	Claire Mouquet-Rivier, PhD, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:	NCT01724073 History of Changes
Other Study ID Numbers:	IRD-UMR204-NA1; IRSAT-DTA Burkina Faso ( Other Identifier: research institute )
First Posted:	November 9, 2012
Last Update Posted:	March 5, 2014
Last Verified:	March 2014

Keywords provided by Claire Mouquet-Rivier, Institut de Recherche pour le Developpement:

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

Additional relevant MeSH terms:

Vitamin A; Micronutrients; Trace Elements	Vitamins; Growth Substances; Physiological Effects of Drugs