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

This study has been withdrawn prior to enrollment.
(Approval denied by national ethical committee of Burkina Faso)
Sponsor:
Collaborators:
IRSAT DTA Burkina Faso
Hopital Yalgado Ouedraogo Burkina Faso
Information provided by (Responsible Party):
Claire Mouquet-Rivier, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT01724073
First received: October 25, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention
Anemia
Dietary Supplement: Leafy vegetable-fish sauce
Dietary Supplement: Leafy vegetable-fish/liver sauce
Dietary Supplement: Misola

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:
  • Change in micronutrient status [ Time Frame: six months ] [ Designated as safety issue: No ]
    iron, zinc and vitamin A status using plasma concentrations

  • Growth [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight, length, mid-upper arm circumference


Secondary Outcome Measures:
  • food consumption [ Time Frame: at t=around 1 month ] [ Designated as safety issue: No ]
    weighed record during one whole day

  • Intake of experimental food [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    the amount of experimental food eaten by each child will be weighed every day

  • Morbidity [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    daily record by questionnaire


Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724073

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

Additional Information:
No publications provided

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
Study First Received: October 25, 2012
Last Updated: March 4, 2014
Health Authority: Burkina Faso: Ministry of Health
France: Institutional Ethical Committee

Keywords provided by Institut de Recherche pour le Developpement:
food to food fortification strategy
leafy vegetable
iron
zinc
vitamin A
growth

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014