AnemiaInstapa-WP4NCT01724073
Regular Consumption of Leafy Vegetable Sauces and Micro-nutrient Status of Young Children in Burkina Faso
A study testing Leafy vegetable-fish sauce, Leafy vegetable-fish/liver sauce and Misola in people with Anemia, run by Institut de Recherche pour le Developpement at 1 site in Burkina Faso.
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. Read more about this study
- Who is it for?
- Ages 12 to 15 months
- Conditions the study is for
- Anemia
- What is being tested?
- Leafy vegetable-fish sauce, Leafy vegetable-fish/liver sauce and Misola
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Dec 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Institut de Recherche en Sciences Aplliquées et Technologie - DTA
Ouagadougou, Centre Region
About this study
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
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Leafy vegetable-fish sauce, Leafy vegetable-fish/liver sauce, Misola
- Keywords
- food to food fortification strategy, leafy vegetable, iron, zinc, vitamin A, growth
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leafy vegetable-fish sauceDietary supplement
Leafy vegetable-fish/liver sauceDietary supplement
MisolaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Leafy vegetable-fish sauce | Experimental | one meal per day, 6 days a week, with leafy vegetable-fish sauce + tô, a local cereal-based paste Receives: Dietary Supplement: Leafy vegetable-fish sauce |
| Leafy vegetable-fish/liver sauce | Experimental | one meal per day, 6 days a week, 5 days with leafy vegetable-fish sauce + tô, 1 day with leafy vegetable-liver sauce + tô Receives: Dietary Supplement: Leafy vegetable-fish/liver sauce |
| Misola | Experimental | one meal per day, 6 days a week, with gruel prepared with the fortified Misola flour Receives: Dietary Supplement: Misola |
| no test food | No intervention | control group receiving no test food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in micronutrient status
iron, zinc and vitamin A status using plasma concentrations
Measured: six months
Growth
Weight, length, mid-upper arm circumference
Measured: 6 months
Secondary outcomes (3)
food consumption
weighed record during one whole day
Measured: at t=around 1 month
Intake of experimental food
the amount of experimental food eaten by each child will be weighed every day
Measured: up to 6 months
Morbidity
daily record by questionnaire
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: Approval denied by national ethical committee of Burkina Faso
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- IRSAT DTA Burkina Faso, Hopital Yalgado Ouedraogo Burkina Faso
- Responsible party
- Principal investigator, Claire Mouquet-Rivier, Institut de Recherche pour le Developpement
- Investigators
- Claire Mouquet-Rivier, PhD, Principal investigator, Institut de Recherche pour le DeveloppementBréhima Diawara, PhD, Principal investigator, Institut de Recherche en Sciences Aplliquées et Technologie - DTA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724073
- Sponsor's protocol ID
- IRD-UMR204-NA1
- Other IDs
- IRSAT-DTA Burkina Faso
- Acronym
- Instapa-WP4
- Status last verified
- Mar 2014
- First submitted
- 25 Oct 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01724073
- Acronym / sponsor ID
- Instapa-WP4 / IRD-UMR204-NA1
- Conditions
- Anemia
- Keywords
- food to food fortification strategy, leafy vegetable, iron, zinc, vitamin A, growth
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Approval denied by national ethical committee of Burkina Faso
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- IRSAT DTA Burkina Faso, Hopital Yalgado Ouedraogo Burkina Faso
- Study start
- Dec 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Leafy vegetable-fish sauce | Experimental | Dietary Supplement: Leafy vegetable-fish sauceone meal per day, 6 days a week, with leafy vegetable-fish sauce + tô, a local cereal-based paste |
| Leafy vegetable-fish/liver sauce | Experimental | Dietary Supplement: Leafy vegetable-fish/liver sauceone meal per day, 6 days a week, 5 days with leafy vegetable-fish sauce + tô, 1 day with leafy vegetable-liver sauce + tô |
| Misola | Experimental | Dietary Supplement: Misolaone meal per day, 6 days a week, with gruel prepared with the fortified Misola flour |
| no test food | No intervention | –control group receiving no test food |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leafy vegetable-fish sauce | Dietary supplement | Leafy vegetable-fish sauce |
| Leafy vegetable-fish/liver sauce | Dietary supplement | Leafy vegetable-fish/liver sauce |
| Misola | Dietary supplement | Misola |
Primary outcome
Change in micronutrient status
Time frame: six months
iron, zinc and vitamin A status using plasma concentrations
Growth
Time frame: 6 months
Weight, length, mid-upper arm circumference
3 secondary outcomes
food consumption
Time frame: at t=around 1 month
Intake of experimental food
Time frame: up to 6 months
Morbidity
Time frame: up to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- The INSTAPA project receives funding from the European Union's Seventh Framework Programme \[FP7/2007-2013\] under grant agreement no 211484Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Mouquet-Rivier, PhD principal investigator
Institut de Recherche pour le Developpement
Bréhima Diawara, PhD principal investigator
Institut de Recherche en Sciences Aplliquées et Technologie - DTA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leafy vegetable-fish sauce, Leafy vegetable-fish/liver sauce and Misola in people with Anemia, run by Institut de Recherche pour le Developpement at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in micronutrient status (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.