Nutrition Deficiency Due to Insufficient FoodAdonutNCT06444555
Adolescent Nutrition in Girls in Burkina Faso and Ethiopia
A study testing BEP supplement and Multiple Micronutrient supplement in people with Nutrition Deficiency Due to Insufficient Food, run by University Ghent at 2 sites in 2 countries.
Trial summary
Adolescents' diets are key to breaking the intergenerational cycle of malnutrition. This study will guide policies and programs on the adequacy, acceptability, and feasibility of implementing balanced energy protein and multiple micronutrient supplementations to fill nutrient gaps in adolescent girls. Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Deficiency Due to Insufficient Food
- What is being tested?
- BEP supplement and Multiple Micronutrient supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 May 2024to 5 Jul 2024
- 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 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Non-pregnant and non-lactating women
- Without any known chronic illness or acute illness affecting appetite
- Permanent residents of the study area
Who cannot join
- Being allergic to peanuts
- Eating disorders or dietary restrictions
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Burkina Faso1 site
Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)
Bobo-Dioulasso
About this study
Official title: Nutritional Needs and Food Supplement Intake of Adolescent Girls in Burkina Faso and Ethiopia
Adolescents' diets are key to breaking the intergenerational cycle of malnutrition. This study will guide policies and programs on the adequacy, acceptability, and feasibility of implementing balanced energy protein and multiple micronutrient supplementations to fill nutrient gaps in adolescent girls. Using a trial, the study will assess dietary intake and nutrient gaps, acceptability of balanced energy protein and multiple micronutrient supplementations. In addition to the trial, the study will the assess willingness to pay for the supplements and the most effective delivery platform and model to reach vulnerable adolescent girls. The most effective delivery platform and model to reach vulnerable adolescent girls cost-effectively will also be assessed through interviews with (inter)national experts, producers, and the donor community.
Read the detailed description
In low- and middle-income countries, it is estimated that each year, 21 million adolescent girls become mothers. Infants of adolescent mothers are at increased risk of delivering babies preterm, with low birth weight or length. Targeting nutrition interventions to improve adolescent girls' diet and nutrition is crucial to breaking the intergenerational cycle of poor growth and development. There is a specific need to assess how a balanced energy protein (BEP) and multiple micronutrient (MMN) supplement interventions can be tailored to adolescent girls and women of reproductive age.
This study aims to assess the adequacy, acceptability, and feasibility of implementing nutritional supplementations to fill nutrient gaps in adolescent girls in resource-limited settings. A trial will specifically:
- assess the short-term acceptability of BEP and MMN supplements
- assess how nutrition supplements increase nutrient adequacy of diets adolescent girls in resources-limited settings;
Using a qualitative component, the study explores the food agency of adolescents and the most effective delivery platform to reach vulnerable adolescent girls cost-effectively. The overall aim is to guide policies and programs on new formulations of nutritional supplements for adolescent girls in resource-limited settings.
- Being tested
- BEP supplement, Multiple Micronutrient supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEP supplementDietary supplement
Also called Balanced energy protein supplement
The BEP supplement used in Burkina Faso is a fortified medium-quantity lipid-based nutrient supplement called Plumpy'Doz. The product is a peanut and milk-based ready-to-use nutritional formulation produced by Nutriset. A peanut-based BEP formulation with a trademark Plumpy'Sup produced by Hilina Enriched Foods PLC will be used in Ethiopia.
Multiple Micronutrient supplementDietary supplement
Also called UNIMAPP
The MMN formulation is based on the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). The formulation contains 15 minerals and vitamins and is administered as a tablet.
| Study group | Role | What they receive |
|---|---|---|
| Balanced Energy Protein Supplement | Experimental | Fortified lipid-based nutrient supplement Receives: Dietary Supplement: BEP supplement |
| Multiple Micronutrient Supplement | Active comparator | The United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). Receives: Dietary Supplement: Multiple Micronutrient supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the supplement
Acceptability to the nutritional supplements, as measured using a 9-item scale (1 "Dislike extremely" up to 9 "Like extremely")
Measured: Day 8 (after 7 days of consumption)
Nutritional adequacy
Mean nutrient adequacy ratio of adolescent diets, using 24 h recall
Measured: Day 8 (after 7 days of consumption)
Secondary outcomes (4)
Willingness to pay for the supplement
Mean household head's willingness to pay values elicited through their bids
Measured: Day 8 (after 7 days of consumption)
Reported consumption of the supplement
Percent of the recommended nutritional supplement consumed during the intervention period, self-reported
Measured: Day 8 (average of 7-day intervention)
Substitution of food and nutrient intake
Substitution of food and nutrition intake at group level, using 24 h recall
Measured: Day 8 (after 7 days of consumption)
Nutrient intake
Mean energy, macronutrient and micronutrient intake between the BEP and MMN group, using 24 h recall
Measured: Day 8 (after 7 days of consumption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start28 May 2024
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Deficiency Due to Insufficient FoodStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 200 adolescent girls will be enrolled in Ethiopia and 200 adolescent girls will be enrolled in Burkina Faso.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, Institut de Recherche en Sciences de la Sante, Burkina Faso, Bill and Melinda Gates Foundation, AfricSanté, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Yemane Berhane, Prof, Principal investigator, Addis Continental Institute of Public HealthFirehiwot Workneh, dr., Study director, Addis Continental Institute of Public HealthMoustapha Drabo, Dr, Study director, University GhentCarl Lachat, Prof, Study chair, University GhentLaeticia Céline Toé, MD, Principal investigator, Institute de Recherche en Sciences de la Santé, Bobo DioulassoHans De Steur, Prof, Principal investigator, University GhentAlemayehu Alemayehu, Dr, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444555
- Sponsor's protocol ID
- ONZ-2024-0038
- Acronym
- Adonut
- Status last verified
- Sep 2024
- First submitted
- 21 May 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be transferred to the donor in a pseudo-anonymised way. After preparing a data-sharing agreement, the investigators will also share food intake data with the Food and Agriculture Organization and World Health Organization (FAO/WHO) of the United Nations Global Individual Food Consumption Data Tool. All research output generated by the project is open access as part of the Grant Agreement with the funder. Given the personal nature of the data, individual data will only be shared after a data transfer agreement with third parties. The informed consent form mentions that data can be shared outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Needs and Food Supplement Intake of Adolescent Girls in Burkina Faso and Ethiopia
- ClinicalTrials.gov ID
- NCT06444555
- Acronym / sponsor ID
- Adonut / ONZ-2024-0038
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Addis Continental Institute of Public Health, Institut de Recherche en Sciences de la Sante, Burkina Faso, Bill and Melinda Gates Foundation, AfricSanté, Burkina Faso
- Study start
- 28 May 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 5 Jun 2024 (actual)
- 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.
Adolescents' diets are key to breaking the intergenerational cycle of malnutrition. This study will guide policies and programs on the adequacy, acceptability, and feasibility of implementing balanced energy protein and multiple micronutrient supplementations to fill nutrient gaps in adolescent girls. Using a trial, the study will assess dietary intake and nutrient gaps, acceptability of balanced energy protein and multiple micronutrient supplementations. In addition to the trial, the study will the assess willingness to pay for the supplements and the most effective delivery platform and model to reach vulnerable adolescent girls. The most effective delivery platform and model to reach vulnerable adolescent girls cost-effectively will also be assessed through interviews with (inter)national experts, producers, and the donor community.
Detailed description
In low- and middle-income countries, it is estimated that each year, 21 million adolescent girls become mothers. Infants of adolescent mothers are at increased risk of delivering babies preterm, with low birth weight or length. Targeting nutrition interventions to improve adolescent girls' diet and nutrition is crucial to breaking the intergenerational cycle of poor growth and development. There is a specific need to assess how a balanced energy protein (BEP) and multiple micronutrient (MMN) supplement interventions can be tailored to adolescent girls and women of reproductive age.
This study aims to assess the adequacy, acceptability, and feasibility of implementing nutritional supplementations to fill nutrient gaps in adolescent girls in resource-limited settings. A trial will specifically:
- assess the short-term acceptability of BEP and MMN supplements
- assess how nutrition supplements increase nutrient adequacy of diets adolescent girls in resources-limited settings;
Using a qualitative component, the study explores the food agency of adolescents and the most effective delivery platform to reach vulnerable adolescent girls cost-effectively. The overall aim is to guide policies and programs on new formulations of nutritional supplements for adolescent girls in resource-limited settings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 200 adolescent girls will be enrolled in Ethiopia and 200 adolescent girls will be enrolled in Burkina Faso.
| Arm | Type | Receives |
|---|---|---|
| Balanced Energy Protein Supplement | Experimental | Dietary Supplement: BEP supplementFortified lipid-based nutrient supplement |
| Multiple Micronutrient Supplement | Active comparator | Dietary Supplement: Multiple Micronutrient supplementThe United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Non-pregnant and non-lactating women
- Without any known chronic illness or acute illness affecting appetite
- Permanent residents of the study area
Key exclusion criteria (2 listed)
- Being allergic to peanuts
- Eating disorders or dietary restrictions
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 |
|---|---|---|
| BEP supplementAlso: Balanced energy protein supplementThe BEP supplement used in Burkina Faso is a fortified medium-quantity lipid-based nutrient supplement called Plumpy'Doz. The product is a peanut and milk-based ready-to-use nutritional formulation produced by Nutriset. A peanut-based BEP formulation with a trademark Plumpy'Sup produced by Hilina Enriched Foods PLC will be used in Ethiopia. | Dietary supplement | Balanced Energy Protein Supplement |
| Multiple Micronutrient supplementAlso: UNIMAPPThe MMN formulation is based on the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). The formulation contains 15 minerals and vitamins and is administered as a tablet. | Dietary supplement | Multiple Micronutrient Supplement |
Primary outcome
Acceptability of the supplement
Time frame: Day 8 (after 7 days of consumption)
Acceptability to the nutritional supplements, as measured using a 9-item scale (1 "Dislike extremely" up to 9 "Like extremely")
Nutritional adequacy
Time frame: Day 8 (after 7 days of consumption)
Mean nutrient adequacy ratio of adolescent diets, using 24 h recall
4 secondary outcomes
Willingness to pay for the supplement
Time frame: Day 8 (after 7 days of consumption)
Reported consumption of the supplement
Time frame: Day 8 (average of 7-day intervention)
Substitution of food and nutrient intake
Time frame: Day 8 (after 7 days of consumption)
Nutrient intake
Time frame: Day 8 (after 7 days of consumption)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Yes. The data will be transferred to the donor in a pseudo-anonymised way. After preparing a data-sharing agreement, the investigators will also share food intake data with the Food and Agriculture Organization and World Health Organization (FAO/WHO) of the United Nations Global Individual Food Consumption Data Tool. All research output generated by the project is open access as part of the Grant Agreement with the funder. Given the personal nature of the data, individual data will only be shared after a data transfer agreement with third parties. The informed consent form mentions that data can be shared outside the study team.
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.
Yemane Berhane, Prof principal investigator
Addis Continental Institute of Public Health
Firehiwot Workneh, dr. study director
Addis Continental Institute of Public Health
Moustapha Drabo, Dr study director
University Ghent
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEP supplement and Multiple Micronutrient supplement in people with Nutrition Deficiency Due to Insufficient Food, run by University Ghent at 2 sites in 2 countries.
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 2 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: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, Ethiopia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability of the supplement (time frame: Day 8 (after 7 days of consumption)). 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 23 Sep 2024.