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COMPLETED
NCT01665378
NA

Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.

Official title: Impact of Pre-Pregnancy Micronutrient Supplementation on Maternal and Child Outcomes

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

5011

Start Date

2011-10

Completion Date

2023-08

Last Updated

2026-10-02

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Multiple Micronutrient

There is no current recommendation for weekly MM supplements for WRA. Therefore, the researchers propose a supplement that contains: The same amounts of iron and folic acid as the weekly, pre-natal IFA supplement; An amount of vitamin D based on the Food and Nutrition Board's Recommended Daily Allowances (RDA); UNICEF/WHO/United Nations University (UNU) recommended amounts of remaining nutrients (UNIMMAP recommendations). The supplement is taken weekly during pre-pregnancy and contains: * 800 μg Vitamin A * 600 IU Vitamin D * 10 mg Vitamin E * 70 mg Vitamin C * 1.4 mg Thiamine * 1.4 mg Riboflavin * 18 mg Niacin * 1.9 mg Vitamin B6 * 2.6 μg Vitamin B12 * 2800 μg Folic Acid * 60 mg Iron * 15 mg Zinc * 2 mg Copper * 65 μg Selenium * 150 μg Iodine

DIETARY_SUPPLEMENT

Iron and Folic Acid

The doses of weekly and daily iron (60mg) and folic acid (2800μg) are based on current WHO recommendations for WRA.

DIETARY_SUPPLEMENT

Folic Acid

It is unethical to have a placebo group as FA is universally recommended for WRA to prevent neural tube defects. Therefore, the control group will receive 2800 μg FA once a week during the pre-pregnancy period. This dosage is safe and meets the minimum recommended intake of 400 μg/d for Women of Reproductive Age (WRA). Recent studies have shown that a weekly dose of 2800 μg FA is as effective as a daily dose of 400 μg in improving folic acid and reducing homocysteine levels among WRA.

Locations (1)

Thai Nguyen University of Medicine and Pharmacy

Thai Nguyen, Thái Nguyên, Vietnam