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

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Folic acid and vitamin B12 fortified flour

Standard bags of fortified cereal-based flours will be prepared at local mills from the common staple cereal food in the area. The dose of vitamins will be added to the flour of the intervention group and mixed with batch mixing technique. The concentration of folic acid and vitamin B12 per 1kg of flour will be 2mg and 0.02mg, respectively. Participants will be supplied with 6 kg bags of flour, which will be enough for 30 days, and 1.5kg bags of flour will be delivered to their home on a weekly basis and lasting for 6 months. Instructions on the preparation of meals and frequency of intake with a weekly compliance sheet will be provided for monitoring the intervention.

OTHER

Unfortified cereal flour

Standard bags of unfortified cereal-based flours will be prepared at local mills from the common staple cereal food in the area. Participants will be supplied with 6 kg bags of flour, which will be enough for 30 days, and 1.5kg bags of flour will be delivered to their home on a weekly basis and lasting for 6 months. Instructions on the preparation of meals and frequency of intake with a weekly compliance sheet will be provided for monitoring the intervention.

Sponsors & Collaborators

• Arba Minch University

  collaborator OTHER

• Institut de Recherche en Sciences de la Sante, Burkina Faso

  collaborator OTHER_GOV

• Addis Ababa University

  collaborator OTHER

• University Ghent

  lead OTHER

Principal Investigators

• Stefaan De Henauw, MD,PHD · University Ghent

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

19 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-06

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• Ethiopia

Study Locations