Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine MDEG2 Pilot Supplementation Trial (MDEG2-PST)
Micronutrient Deficiencies, Hyperhomocysteinemia
About this trial
This is an interventional treatment trial for Micronutrient Deficiencies
Eligibility Criteria
Inclusion Criteria:
Pre-menopausal women aged 18-45 years
- Non-pregnant, confirmed by pregnancy urine test at eligibility screen
- Non-lactating (at least 9 months post-partum)
- No plan to conceive in the ensuing 3 months, asked verbally by field worker
- No plans to travel
- Healthy with no current illness and no chronic health problems, asked verbally by field worker
Exclusion Criteria:
Known history of chronic illness (particularly cardiovascular disease, renal disease, thyroid disease, cancer)
- Taking B vitamin or multivitamin supplements.
- Taking medication for prevention of seizures (e.g. Carbamazepine).
Sites / Locations
- Keneba Field Station
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
oral nutritional supplementation
oral nutritional supplementation, UNIMMAP
control
Daily novel micronutrient supplement: 800 μg folic acid, 5.2 μg cyanocobalamin (B12), 2.8 mg Riboflavin-5'- phosphate (B2), 4g trimethylglycine (betaine) in drink powder form. The drink will be dissolved in 200ml of water and taken daily for 12 weeks
The United Nations Multiple Micronutrient Preparation (UNIMMAP) supplement is a capsule containing 15 micronutrients (vitamins A, D, E, B1, B2, B6, B12, C, Niacin, Folic Acid, Fe, Zn, Cu, I, Se) at the Recommended Daily Allowance level. UNIMMAP will be provided in capsule form and taken daily with water for 12 weeks.
no treatment will be given to this group observation only (no placebo)