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Impact of Iron/Folic Acid Versus Multimicronutrient Versus Folic Acid Supplements During Pregnancy on Mortality, Morbidity, and Complications During Pregnancy, Labor, and Delivery: A Randomized Controlled Trial in China
The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid alone.
In the project area in China, the rate of perinatal mortality (stillbirths and infant deaths within 6 days of birth) is two times that of the United States. Causes of perinatal mortality include, but are not limited to, low birth weight and preterm delivery. Anemia (low hemoglobin) among pregnant women is associated with low birth weight and preterm delivery and also is elevated in the project area. Supplements of iron, folic acid, and other vitamins and minerals can prevent anemia among pregnant women, but the effects of these supplements on other maternal and infant health outcomes are unclear. Since 1993, the People's Republic of China has recommended that newly married women, and those who plan pregnancy, take 400μg of folic acid daily through the first trimester of pregnancy. Although WHO recommends that pregnant women take iron and folic acid supplements, there is currently no national recommendation that pregnant women in China take iron or other vitamin or mineral supplements (other than folic acid). UNICEF is now testing a prenatal vitamin and mineral supplement in programs to prevent low birth weight. Our study will provide additional information about the health impact of the UNICEF prenatal supplement versus an iron and folic acid supplement versus folic acid alone. Comparisons: * Infants of women who receive daily prenatal supplements that contain 400μg folic acid alone, will be compared with infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid. * Infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid will be compared with infants of women who receive a daily supplement containing 30 mg iron, 400μg folic acid and other vitamins and minerals (UNICEF formulation).
Age
20 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Fengrun Maternal and Child Health Institute
Fengrun, Hebei, China
Yuanshi Maternal and Child Health Institute
Huaiyang, Hebei, China
Laoting Maternal and Child Health Institute
Laoting, Hebei, China
Mancheng Maternal and Child Health Institute
Mancheng, Hebei, China
Xianghe Maternal and Child Health Institute
Xianghe, Hebei, China
Start Date
May 1, 2006
Primary Completion Date
December 1, 2009
Completion Date
December 1, 2010
Last Updated
March 21, 2011
18,962
ACTUAL participants
folic acid
DIETARY_SUPPLEMENT
folic acid plus iron
DIETARY_SUPPLEMENT
supplements with multiple vitamins and minerals
DIETARY_SUPPLEMENT
Lead Sponsor
Centers for Disease Control and Prevention
NCT06918236
NCT05901688
Data Source & Attribution
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