Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

Phase 3

Completed

• Conditions: Perinatal Mortality; Stillbirth; Neonatal Mortality
• Interventions: Dietary Supplement: folic acid; Dietary Supplement: folic acid plus iron; Dietary Supplement: supplements with multiple vitamins and minerals

• Registration Number: NCT00133744
• Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-24
• Study Start: 2006-05
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-18
• Last Update Posted: 2011-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18962

Inclusion Criteria

• Live in one of the study counties (Laoting, Mancheng, Fengrun, Xianghe, Yuanshi)
• Can follow instructions
• Can swallow pills

Exclusion Criteria

• >= 20 weeks gestation at enrollment
• Previous live birth
• Anemic (hemoglobin [Hb] <10 g/dl in 1st trimester and < 9.5 g/dl in 2nd trimester) at enrollment
• Current use of iron or other vitamin or mineral supplements (except folic acid)
• Age < 20 years at enrollment
• Under treatment for anemia at enrollment
• Refuse to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A, 1	folic acid	-
A, 2	folic acid plus iron	-
A, 3	supplements with multiple vitamins and minerals	Multiple micronutrient supplement

Primary Outcome Measures

Name	Time	Method
Perinatal mortality, i.e., the number of stillbirths (fetal deaths of 28 weeks or more of gestation) and the number of deaths within the first 0-6 days of life per 1000 births (live births and stillbirths)	20 weeks gestation to 6 days postpartum

Secondary Outcome Measures

Name	Time	Method
Maternal anemia	4-8 weeks postpartum
Infant gestational age at birth, preterm delivery	delivery
Infant birth weight, low birth weight	at birth
Infant low weight-for-height	infant age 6 months and 12 months
Infant anemia	6 months and 12 months of age
maternal gastrointestinal side effects	monthly from a month after enrollment until delivery

Trial Locations

Locations (5)

Laoting Maternal and Child Health Institute; 🇨🇳 Laoting, Hebei, China

Yuanshi Maternal and Child Health Institute; 🇨🇳 Yuanshi, Hebei, China

Mancheng Maternal and Child Health Institute; 🇨🇳 Mancheng, Hebei, China

Fengrun Maternal and Child Health Institute; 🇨🇳 Fengrun, Hebei, China

Xianghe Maternal and Child Health Institute; 🇨🇳 Xianghe, Hebei, China