Status:
COMPLETED
Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine MDEG2 Pilot Supplementation Trial
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Micronutrient Deficiencies
Hyperhomocysteinemia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This micronutrient supplementation study is a 3-arm randomized controlled trial, unblinded, with 125 women per arm. Non-pregnant, non-lactating healthy women of reproductive age in West Kiang, The Gam...
Detailed Description
In rural Gambia women experience considerable variation in their diet by season. In the dry season women have particular micronutrient deficiencies that can disrupt one-carbon metabolism pathways. In ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2018
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT03431597
Start Date
April 26 2018
End Date
November 26 2018
Last Update
January 22 2019
Active Locations (1)
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1
Keneba Field Station
Banjul, The Gambia