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Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine MDEG2 Pilot Supplementation Trial (MDEG2-PST)

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ClinicalTrials.gov Identifier: NCT03431597
Recruitment Status : Active, not recruiting
First Posted : February 13, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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 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.


Condition or disease Intervention/treatment Phase
Micronutrient Deficiencies Hyperhomocysteinemia Dietary Supplement: novel micronutrient Dietary Supplement: existing micronutrient supplement, UNIMMAP Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3-arm randomized controlled trial, unblinded, with 125 women per arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine in Non-pregnant Women of Reproductive Age
Actual Study Start Date : April 26, 2018
Actual Primary Completion Date : July 20, 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: oral nutritional supplementation
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
Dietary Supplement: novel micronutrient
The supplements will be supplied to participants on a daily basis. The novel micronutrient supplement will be provided in powder form with instructions to dissolve one sachet in 250ml of clean water

Active Comparator: oral nutritional supplementation, UNIMMAP
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.
Dietary Supplement: existing micronutrient supplement, UNIMMAP
UNIMMAP will be provided in tablet form and given one daily

No Intervention: control
no treatment will be given to this group observation only (no placebo)



Primary Outcome Measures :
  1. Difference in plasma homocysteine concentration between the drink powder and control arms at end-lineplasma Hcy vs control [ Time Frame: after 12 weeks ]
    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


Secondary Outcome Measures :
  1. Difference in plasma homocysteine concentration between the drink powder and UNIMMAP arms at end-line [ Time Frame: after 12 weeks ]
    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.

  2. Difference in plasma homocysteine concentration between the the drink powder and UNIMMAP arms at mid-line [ Time Frame: after 6 weeks ]
    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

  3. Difference in blood pressure (systolic and diastolic) and pulse between the drink powder and control arms at end-line [ Time Frame: after 12 weeks ]
    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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   A list of eligible women within West Kiang will be generated using the MRCG Keneba Health and Demographic Surveillance System (HDSS) database
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431597


Locations
Gambia
Keneba Field Station
Banjul, Gambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Andrew Prentice, PhD Medical Research Council Unit, The Gambia

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03431597     History of Changes
Other Study ID Numbers: SCC 1575
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Amino Acid Metabolism, Inborn Errors
Hyperhomocysteinemia
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs