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Completed

NCT Number: NCT00133744

Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

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.

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Key information

Conditions

Perinatal Mortality Anemia Birth Weight Body Weight Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Hematologic Diseases Hemic and Lymphatic Diseases Neonatal Mortality Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Premature Birth Signs and Symptoms Stillbirth Urogenital Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fengrun Maternal and Child Health Institute, Fengrun, Hebei, China

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic Acid

Dietary Supplement

pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid

folic acid plus iron

Dietary Supplement

pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe

supplements with multiple vitamins and minerals

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Maternal anemia

    Time frame: 24-28 weeks gestation

  2. Maternal anemia

    Time frame: 4-8 weeks postpartum

  3. Infant gestational age at birth, preterm delivery

    Time frame: delivery

  4. Infant birth weight, low birth weight

    Time frame: at birth

  5. Infant low weight-for-height

    Time frame: infant age 6 months and 12 months

  6. Infant anemia

    Time frame: 6 months and 12 months of age

  7. maternal gastrointestinal side effects

    Time frame: monthly from a month after enrollment until delivery

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Aug 24, 2005
Registry last updated
Mar 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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