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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. A deficiency of either vitamin will predispose teenagers to many diseases, which persist across their lifespan. Fortification of food with micronutrients has been promoted to reduce micronutrient deficiencies. A large segment of vulnerable populations in low- and middle-income countries (LMICs) resides in rural settings and has limited access to large-scale commercialized fortified foods. In such operational constraints, the use of locally (small-scale) fortified cereals could be an alternative intervention. The study aims to evaluate the effectiveness of small scale folic acid and vitamin B12 fortified cereals in improving folate and vitamin B12 status, growth velocity, puberty status, anaemia, cognitive development and mental health among teenage girls, in rural rift valley of Ethiopia.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 13
Maximum Age: 19
Healthy Volunteers: t
View:

⁃ 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.

Locations
Other Locations
Ethiopia
Arba Minch Health and Demographic Surveillance System sites
RECRUITING
Arba Minch
Arba Minch University
NOT_YET_RECRUITING
Arba Minch
Contact Information
Primary
Souheila Abbeddou, MSc, PHD
Souheila.Abbeddou@UGent.be
+32467630892
Backup
Eshetu Tariku, MPH
eshetuzerihun.tariku@ugent.be
+251917835302
Time Frame
Start Date: 2023-09-06
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 474
Treatments
Placebo_comparator: Control group
Teenage girls randomly assigned to the control group will receive a standard bag of unfortified cereal flours every week for six months.
Experimental: folic acid & vit B12 fortified flour
Teenage girls randomly assigned to the control group will receive a standard bag of cereal flours fortified with folic acid and Vit B12 every week for six months.
Sponsors
Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso, Arba Minch University, Addis Ababa University
Leads: University Ghent

This content was sourced from clinicaltrials.gov