Fortifying cereals with folic acid and vitamin B12 for teenage girls
Does Small Scale Cereal-based Fortification Hold the Key to Improved Micronutrient Status in Ethiopia? The Case of Folic Acid and Vitamin B12 in Teenage Girls in Arba Minch, Ethiopia
This study tests if adding folic acid and vitamin B12 to cereals can help teenage girls in rural Ethiopia grow better, think clearer, and feel less tired or sad.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 474 (estimated) |
| Ages | 13 Years to 19 Years |
| Sex | Female |
| Sponsor | University Ghent Academic / other |
| Locations | 2 sites (Arba Minch and 1 other locations) |
| Trial ID | NCT06100146 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of small-scale fortification of cereals with folic acid and vitamin B12 among teenage girls in rural Ethiopia. It aims to improve nutritional status, growth velocity, and cognitive development while reducing anemia and depressive symptoms. The intervention involves providing fortified flour compared to unfortified cereal flour, with participants monitored over a minimum of six months. The study addresses the challenges of micronutrient deficiencies in low- and middle-income countries, particularly among vulnerable populations.
Who should consider this trial
Good fit: Ideal candidates for this study are teenage girls aged 13 to 19 living in rural areas of Ethiopia who are not chronically ill or severely undernourished.
Not a fit: Patients who are pregnant, lactating, or have specific chronic illnesses such as diabetes or severe anemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the health and cognitive development of teenage girls, leading to better maternal and child health outcomes.
How similar studies have performed: While there is limited evidence on small-scale cereal fortification in Ethiopia, similar approaches in other regions have shown promise in addressing micronutrient deficiencies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Teenage girls between 13 and 19 years of age who live in households at Arba Minch Health and Demographic Surveillance Sites (AM-HDSS) are eligible to participate in the study if: * One or both of their parents signed an informed consent form and the girl's agreement. * Their parents and the girl planned to stay in the study area during the period of the study (minimum 6 months) in the kebele. * Both parents and girls accept the intervention packages including blood draws and home visits. Exclusion Criteria: * Chronically ill girls diagnosed with diabetes and asthma; * Severely undernourished girls (defined as body mass index z score \< -3 standard deviations of the median World Health Organization reference population); * Severely anaemic girls (Hb concentration \<80g/L); * Teenage girls who are pregnant, lactating or taking IFA/B12 supplements; * Diagnosed hemoglobinopathy (sickle cell or thalassemia); * Diagnosed liver diseases like acute hepatitis, cirrhosis, hepatocellular carcinoma, and metastatic liver disease
Where this trial is running
Arba Minch and 1 other locations
- Arba Minch Health and Demographic Surveillance System sites — Arba Minch, Ethiopia (Recruiting)
- Arba Minch University — Arba Minch, Ethiopia (Not_yet_recruiting)
Study contacts
- Principal investigator: Stefaan De Henauw, MD,PHD — University Ghent
- Study coordinator: Souheila Abbeddou, MSc, PHD
- Email: Souheila.Abbeddou@UGent.be
- Phone: +32467630892
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.