Hyperhomocysteinemia Clinical Trial
— MDEG2-PSTOfficial title:
Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine in Non-pregnant Women of Reproductive Age
Verified date | January 2019 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Gambia, will be randomized to 12 weeks of daily supplementation of either a) novel
micronutrient supplement, b) a United Nations International Multiple Micronutrient
Preparation (UNIMMAP) tablet or c) no intervention (control). The novel micronutrient
supplement is a drink powder providing 800 µg folic acid, 5.2 µg cyanocobalamin (B12), 2.8 mg
Riboflavin-5'-phosphate (B2), and 4g trimethylglycine (betaine). UNIMMAP contains 15
micronutrients at the Recommended Daily Allowance level. The aim is to test the effectiveness
of the supplements on correcting micronutrient deficiencies in the dry season and to reduce
homocysteine levels. The hypothesis is that the new drink powder will be the most effective
supplement, causing a reduction in 1 µmol/L compared to the control group after
supplementation.
The supplements will be supplied to participants on a daily basis by Community-based Birth
Attendants (CBCs). The CBCs will observe consumption of the supplement. The novel
micronutrient supplement will be provided in powder form with instructions to dissolve one
sachet in a cup of 200ml water. UNIMMAP will be provided in capsule form to be taken with
water. Women will provide one 10ml fasted venous blood sample at baseline and another after 6
and 12 weeks of supplementation. At each time point they will also have their blood pressure
and anthropometry assessed and provide a urine pregnancy test.
Correcting micronutrient deficiencies is extremely important for the long-term health of
women, and in particular around the time of conception and throughout pregnancy since
micronutrients are needed for the proper physical and cognitive development of the baby.
Certain micronutrients are required for adding a methyl group to places on DNA ('DNA
methylation'). The pattern of these methyl groups can help determine whether a gene is
switched on or off. Correct functioning of DNA methylation processes is therefore of critical
importance for fetal development. High levels of homocysteine can impede DNA methylation,
therefore supplements that reduce homocysteine may not only be beneficial for the mother but
also for the developing child. The most effective supplement in this trial will be considered
for testing in larger pregnancy trials.
Status | Completed |
Enrollment | 298 |
Est. completion date | November 26, 2018 |
Est. primary completion date | July 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Gambia | Keneba Field Station | Banjul |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine |
Gambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in plasma homocysteine concentration between the drink powder and control arms at end-lineplasma Hcy vs control | To compare the effect of a novel micronutrient supplement taken daily for 12 weeks in the dry season on lowering plasma homocysteine versus the control group supplement taken daily for 12 weeks in the dry season on lowering plasma homocysteine (Hcy) versus the control group | after 12 weeks | |
Secondary | Difference in plasma homocysteine concentration between the drink powder and UNIMMAP arms at end-line | To compare the effect of a novel micronutrient supplement taken daily for 12 weeks in the dry season on lowering plasma homocysteine versus the UNIMMAP group. | after 12 weeks | |
Secondary | Difference in plasma homocysteine concentration between the the drink powder and UNIMMAP arms at mid-line | To compare the effect of a novel micronutrient supplement taken daily for 6 weeks in the dry season on lowering plasma homocysteine versus the UNIMMAP group | after 6 weeks | |
Secondary | Difference in blood pressure (systolic and diastolic) and pulse between the drink powder and control arms at end-line | To compare the effect of a novel micronutrient supplement taken daily for 12 weeks in the dry season on lowering blood pressure and pulse versus the control group | after 12 weeks |
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