Adolescent Nutrition in Girls in Burkina Faso and Ethiopia

Nutrition Deficiency Due to Insufficient Food Clinical Trial

— Adonut  

Official title:

Nutritional Needs and Food Supplement Intake of Adolescent Girls in Burkina Faso and Ethiopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06444555
• Other study ID #: ONZ-2024-0038
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2024
• Source: University Ghent
• Contact: Carl Lachat, Prof
• Phone: 003292649377
• Email: carl.lachat[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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:

1. assess the short-term acceptability of BEP and MMN supplements

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

Eligibility criteria are all based on self-reported information

Inclusion criteria:

• Non-pregnant and non-lactating women

• Without any known chronic illness or acute illness affecting appetite

• Permanent residents of the study area

Exclusion criteria:

• Being allergic to peanuts

• Eating disorders or dietary restrictions

Related Conditions & MeSH terms

• Nutrition Deficiency Due to Insufficient Food

Intervention

Dietary Supplement:
• BEP 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 supplement
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.

Locations

Country	Name	City	State
Burkina Faso	Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)	Bobo-Dioulasso
Ethiopia	Addis Continental Institute of Public Health	Addis Ababa

Sponsors (5)

Lead Sponsor	Collaborator
University Ghent	Addis Continental Institute of Public Health, AfricSanté, Burkina Faso, Bill and Melinda Gates Foundation, Institut de Recherche en Sciences de la Sante, Burkina Faso

Countries where clinical trial is conducted

Burkina Faso,  Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the supplement	Acceptability to the nutritional supplements, as measured using a 9-item scale (1 "Dislike extremely" up to 9 "Like extremely")	Day 8 (after 7 days of consumption)
Primary	Nutritional adequacy	Mean nutrient adequacy ratio of adolescent diets, using 24 h recall	Day 8 (after 7 days of consumption)
Secondary	Willingness to pay for the supplement	Mean household head's willingness to pay values elicited through their bids	Day 8 (after 7 days of consumption)
Secondary	Reported consumption of the supplement	Percent of the recommended nutritional supplement consumed during the intervention period, self-reported	Day 8 (average of 7-day intervention)
Secondary	Substitution of food and nutrient intake	Substitution of food and nutrition intake at group level, using 24 h recall	Day 8 (after 7 days of consumption)
Secondary	Nutrient intake	Mean energy, macronutrient and micronutrient intake between the BEP and MMN group, using 24 h recall	Day 8 (after 7 days of consumption)