Status:
UNKNOWN
Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls
Lead Sponsor:
University Ghent
Collaborating Sponsors:
Arba Minch University
Institut de Recherche en Sciences de la Sante, Burkina Faso
Conditions:
Folate Deficiency
Vitamin B 12 Deficiency
Eligibility:
FEMALE
13-19 years
Phase:
NA
Brief 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 def...
Detailed Description
Folic acid (FA) 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT06100146
Start Date
September 6 2023
End Date
December 31 2025
Last Update
December 20 2023
Active Locations (2)
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1
Arba Minch Health and Demographic Surveillance System sites
Arba Minch, Ethiopia, 21
2
Arba Minch University
Arba Minch, Ethiopia