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

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.

Conditions

• Anemia
• Intrauterine Growth Retardation
• Preterm Delivery
• Iron 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.

Sponsors & Collaborators

• Micronutrient Initiative

  collaborator OTHER

• The Mathile Institute for the Advancement of Human Nutrition

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Usha Ramakrishnan, PhD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2014-09-30

Completion

2019-12-31

Countries

• Vietnam