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

NACompletedINTERVENTIONAL
Enrollment

5,011

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

September 30, 2014

Study Completion Date

December 31, 2019

Conditions
AnemiaIntrauterine Growth RetardationPreterm DeliveryIron Deficiency
Interventions
DIETARY_SUPPLEMENT

Multiple Micronutrient

"There is no current recommendation for weekly MM supplements for WRA. Therefore, we 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/UNU recommended amounts of remaining nutrients (UNIMMAP recommendations). The supplement is taken weekly during pre-pregnancy.~Vitamin A (μg) 800 Vitamin D (IU) 600 Vitamin E (mg) 10 Vitamin C (mg) 70 Thiamine (mg) 1.4 Riboflavin (mg) 1.4 Niacin (mg) 18 Vitamin B6 (mg) 1.9 Vitamin B12 (μg) 2.6 Folic acid (μg)\* 2800 Iron (mg)\* 60 Zinc (mg) 15 Copper (mg) 2 Selenium (μg) 65 Iodine (μg) 150"

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.

Trial Locations (1)

24000

Thainguyen University of Medicine and Pharmacy, Hành Phố Thái Nguyên

All Listed Sponsors
collaborator

Micronutrient Initiative

OTHER

collaborator

The Mathile Institute for the Advancement of Human Nutrition

OTHER

lead

Emory University

OTHER

NCT01665378 - Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes | Biotech Hunter | Biotech Hunter