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

Anemia Clinical Trial

— Instapa-WP4  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01724073
• Other study ID #: IRD-UMR204-NA1
• Secondary ID: IRSAT-DTA Burkin
• Status: Withdrawn
• Phase: N/A
• First received: October 25, 2012
• Last updated: March 4, 2014
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of HealthFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 15 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• Leafy vegetable-fish sauce

• Leafy vegetable-fish/liver sauce

• Misola

Locations

Country	Name	City	State
Burkina Faso	Institut de Recherche en Sciences Aplliquées et Technologie - DTA	Ouagadougou	Centre

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Hopital Yalgado Ouedraogo Burkina Faso, IRSAT DTA Burkina Faso

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in micronutrient status	iron, zinc and vitamin A status using plasma concentrations	six months	No
Primary	Growth	Weight, length, mid-upper arm circumference	6 months	No
Secondary	food consumption	weighed record during one whole day	at t=around 1 month	No
Secondary	Intake of experimental food	the amount of experimental food eaten by each child will be weighed every day	up to 6 months	No
Secondary	Morbidity	daily record by questionnaire	up to 6 months	No

External Links

•   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