Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

March 18, 2011 updated by: Centers for Disease Control and Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18962

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Fengrun, Hebei, China, 064000
        • Fengrun Maternal and Child Health Institute
      • Laoting, Hebei, China, 063600
        • Laoting Maternal and Child Health Institute
      • Mancheng, Hebei, China, 072150
        • Mancheng Maternal and Child Health Institute
      • Xianghe, Hebei, China, 065400
        • Xianghe Maternal and Child Health Institute
      • Yuanshi, Hebei, China, 051130
        • Yuanshi Maternal and Child Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A, 1
Dietary supplement: folic acid
pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid
Experimental: A, 2
Dietary supplement: folic acid plus iron
pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe
Experimental: A, 3
Multiple micronutrient supplement
Dietary supplement: supplements with multiple vitamins and minerals
pills, one per day, from the first prenatal visit until delivery; folic acid 400 mcg, Fe 30 mg, vitamin(vit) A 800 mcg, vit E 10 mg, vit D 5 mcg, vit C 70 mg, vit B1 1.4 mg, vit B2 1.4 mg, vit B6 1.9 mg, vit B12 2.6 mcg, Niacin 18 mg, Zn 15 mg, Cu 2mg, Iodine 150 mcg, Selenium 65 mcg
Other Names:
  • UNIMMAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 20 weeks gestation to 6 days postpartum
20 weeks gestation to 6 days postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal anemia
Time Frame: 24-28 weeks gestation
24-28 weeks gestation
Maternal anemia
Time Frame: 4-8 weeks postpartum
4-8 weeks postpartum
Infant gestational age at birth, preterm delivery
Time Frame: delivery
delivery
Infant birth weight, low birth weight
Time Frame: at birth
at birth
Infant low weight-for-height
Time Frame: infant age 6 months and 12 months
infant age 6 months and 12 months
Infant anemia
Time Frame: 6 months and 12 months of age
6 months and 12 months of age
maternal gastrointestinal side effects
Time Frame: monthly from a month after enrollment until delivery
monthly from a month after enrollment until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Weicheng You, MD, MBA, Peking University Health Science Center, Beijing China
  • Study Director: Jianmeng Liu, MD, PhD, Institute of Reproductive and Child Health, Peking University Health Science Center, Beijing China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

March 21, 2011

Last Update Submitted That Met QC Criteria

March 18, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCCDPHP-4084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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