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

NCT06100146

CompletedNA

Sponsor: University Ghent

Conditions: Folate Deficiency, Vitamin B 12 Deficiency, Anemia, Megaloblastic, Cognitive Development, Depressive Symptoms

Interventions: Folic acid and vitamin B12 fortified flour, Unfortified cereal flour

Countries: Ethiopia

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 overview

Sex: FEMALE

Age: 13 Years to 19 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (2)
  • Arba Minch, Ethiopia
  • Arba Minch, Ethiopia