CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,011 enrolled
Drug / intervention
Multiple Micronutrient +2 moredietary
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01665378
NCT01665378N/ACompleted

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

Emory University·interventional·Posted Aug 15, 2012·Updated Jul 8, 2021

In Brief

A clinical study evaluating Multiple Micronutrient, Iron and Folic Acid, and 1 other intervention for Anemia and 3 related conditions. Completed, enrolled 5,011 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesVietnam

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 15, 2012
Enrollment StartOct 1, 2011
Primary CompletionSep 1, 2014
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.9 years ago

Interventions

Multiple Micronutrientdietary

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

Iron and Folic Aciddietary

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

Folic Aciddietary

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.