Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 3

Conditions: Perinatal Mortality; Stillbirth; Neonatal Mortality

Treatments: Dietary Supplement: folic acid; Dietary Supplement: supplements with multiple vitamins and minerals; Dietary Supplement: folic acid plus iron

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00133744

CDC-NCCDPHP-4084

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18,962 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18,962 participants in 3 patient groups

A, 1

Active Comparator group

Treatment:

Dietary Supplement: folic acid

A, 2

Experimental group

Treatment:

Dietary Supplement: folic acid plus iron

A, 3

Experimental group

Description:

Multiple micronutrient supplement

Treatment:

Dietary Supplement: supplements with multiple vitamins and minerals