People's Republic of China

Project Name: Randomized Controlled Trial to Compare the Effects of Micronutrient Supplements

Summary: This project is a study of nutritional supplements taken by pregnant women and the effects on mortality, morbidity, and complications during pregnancy, labor, and delivery. The following supplements are being studied:

• Iron plus folic acid supplements
• Multi-micronutrient supplements
• Folic acid supplements

Start Date: July 2006

Background

Although the World Health Organization (WHO) recommends that women take iron and folic acid supplements during pregnancy and the United Nations Children's Fund (UNICEF) recommends that women take multiple micronutrients during pregnancy, only limited information has been collected on the clinical effects of these supplements on maternal and infant health. Randomized controlled trials can provide the basis for evaluating the effectiveness of vitamin and mineral supplements for preventing maternal and infant morbidity and mortality, and for evaluating supplement safety.

The CDC is assisting the People's Republic of China and its partners in designing and implementing a randomized controlled trial and in ensuring appropriate quality controls for collecting biomarker data. The CDC will also collaborate in publishing the results of this study.

Purposes

The project has the following purposes:

• Determine which of the following three supplements, when given from the first prenatal visit through delivery, reduces the rate of perinatal mortality without an increase in adverse effects: iron plus folic acid, multiple micronutrient supplements, or folic acid alone
• Determine which of the following three supplements, when given from the first prenatal visit through delivery, reduces the rates of maternal and infant complications during pregnancy, labor, delivery and the postpartum period without an increase in adverse effects: iron plus folic acid, multiple micronutrient supplements, or folic acid alone

Target Group(s)

The target groups consist of pregnant women aged 20 to 49 years and their newborns aged 0 to 12 months.

Progress

• In November 2002, five counties in Hebei province were selected for the trial program.
• In January 2003, the initial training on hemoglobin measurement and height/weight measurements was completed.
• During 2005,  the study proposal and operational manual were finalized, and a 4-month pilot test was carried out.
• In July 2006, official recruitment started and is ongoing. The target sample size is 18,750 women aged 20 to 49 years and their newborns aged 0 to 12 months.

Future Plans

Future plans include the following activities:

• March 2009: Enroll last women in the study.
• October 2009: Monitor deliveries of last women enrolled.
• January 2010: Follow up with last women enrolled at 6 weeks postpartum.
• October 2010: Follow up with last infants at one-year birthdays.
• June 2011: Conclude study and disseminate findings.

Partners

The CDC works with the following partners on this project:

• Peking University Health Science Center

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