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Search / Trial NCT06100146

Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls

Launched by UNIVERSITY GHENT · Oct 20, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Small Scale Fortification Folic Acid Vitamin B12 Anemia Cognitive Development Teenage Girls

ClinConnect Summary

This clinical trial is studying whether adding folic acid and vitamin B12 to locally made cereals can help improve the health of teenage girls in rural Ethiopia. These vitamins are important for many body functions, including cell growth and red blood cell creation. The goal is to see if these fortified cereals can boost vitamin levels, support healthy growth and puberty, reduce anemia, and improve mental health and cognitive development in girls aged 13 to 19 who may be lacking these nutrients.

To participate, girls need to live in the study area with their families and have their parents' consent. However, those who are severely ill, undernourished, or pregnant cannot join the study. If eligible, participants can expect to receive the fortified cereals and may have blood tests and home visits during the study period, which lasts at least six months. This research is important because it seeks to find practical solutions for improving nutrition in communities that might not have access to commercially fortified foods.

Gender

FEMALE

Eligibility 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

About University Ghent

University Ghent is a prestigious Belgian research institution renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a multidisciplinary approach, the university fosters collaboration among leading experts in various fields, ensuring rigorous study design and ethical standards. University Ghent is dedicated to exploring new therapeutic modalities and enhancing healthcare outcomes, making significant contributions to both local and global health landscapes. Its state-of-the-art facilities and emphasis on research excellence position it as a pivotal sponsor in the realm of clinical research.

Locations

Arba Minch, , Ethiopia

Arba Minch, , Ethiopia

Patients applied

0 patients applied

Trial Officials

Stefaan De Henauw, MD,PHD

Principal Investigator

University Ghent

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported