- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01724073
Regular Consumption of Leafy Vegetable Sauces and Micro-nutrient Status of Young Children in Burkina Faso (Instapa-WP4)
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 Overview
Status
Conditions
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Centre
-
Ouagadougou, Centre, Burkina Faso
- Institut de Recherche en Sciences Aplliquées et Technologie - DTA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
|
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
|
|
Experimental: Misola
one meal per day, 6 days a week, with gruel prepared with the fortified Misola flour
|
|
No Intervention: no test food
control group receiving no test food
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in micronutrient status
Time Frame: six months
|
iron, zinc and vitamin A status using plasma concentrations
|
six months
|
Growth
Time Frame: 6 months
|
Weight, length, mid-upper arm circumference
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
food consumption
Time Frame: at t=around 1 month
|
weighed record during one whole day
|
at t=around 1 month
|
Intake of experimental food
Time Frame: up to 6 months
|
the amount of experimental food eaten by each child will be weighed every day
|
up to 6 months
|
Morbidity
Time Frame: up to 6 months
|
daily record by questionnaire
|
up to 6 months
|
Collaborators and Investigators
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRD-UMR204-NA1
- IRSAT-DTA Burkina Faso (Other Identifier: research institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
-
University of California, DavisInstituto Mexicano del Seguro Social; Thrasher Research Fund; Mexican National... and other collaboratorsCompleted
-
Incyte CorporationActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom
-
Peking Union Medical College HospitalRecruiting
-
Alexion PharmaceuticalsWithdrawnWarm Autoimmune Hemolytic AnemiaUnited States
Clinical Trials on Leafy vegetable-fish sauce
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Helen Keller International; Grand... and other collaboratorsCompletedThiamin DeficiencyCambodia
-
Queen's University, BelfastCompletedBlood PressureUnited Kingdom
-
Academia Sinica, TaiwanNational Taiwan University HospitalCompleted
-
Academia Sinica, TaiwanNot yet recruiting
-
University of GlasgowActive, not recruitingSarcopeniaUnited Kingdom
-
University of CopenhagenCompletedMetabolic SyndromeDenmark
-
Auburn UniversityCompletedColon Cancer PreventionUnited States
-
University Hospital, ToursInstitut Cancerologie de l'OuestTerminatedMetastatic Breast Cancer | Estrogen Receptor Positive Tumor | Progesterone Receptor Positive Tumor | HER-2 Negative TumorFrance
-
University of LeedsCompletedHip Fracture (First Incidence of)United Kingdom