Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00133744
First received: August 22, 2005
Last updated: March 18, 2011
Last verified: March 2011

August 22, 2005
March 18, 2011
May 2006
December 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
  • - Perinatal mortality, i.e., the number of stillbirths
  • - Gastrointestinal side effects at monthly visits.
  • (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 still
  • births).
Complete list of historical versions of study NCT00133744 on ClinicalTrials.gov Archive Site
  • Maternal anemia [ Time Frame: 24-28 weeks gestation ] [ Designated as safety issue: No ]
  • Maternal anemia [ Time Frame: 4-8 weeks postpartum ] [ Designated as safety issue: No ]
  • Infant gestational age at birth, preterm delivery [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Infant birth weight, low birth weight [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • Infant low weight-for-height [ Time Frame: infant age 6 months and 12 months ] [ Designated as safety issue: No ]
  • Infant anemia [ Time Frame: 6 months and 12 months of age ] [ Designated as safety issue: No ]
  • maternal gastrointestinal side effects [ Time Frame: monthly from a month after enrollment until delivery ] [ Designated as safety issue: Yes ]
  • - Maternal anemia between 24 and 28 weeks gestation,
  • - Maternal anemia at 4-8 weeks postpartum
  • - Infant gestational age at birth, preterm delivery
  • - Infant birth weight, low birth weight
  • - Infant low weight-for-height at age 6 and
  • 12 months
  • - Infant low weight-for-age at age 6 and 12 months
  • - Infant low height-for-age at age 6 and 12 months
  • - Infant anemia at age 6 and 12 months
Not Provided
Not Provided
 
Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality
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).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Perinatal Mortality
  • Stillbirth
  • Neonatal Mortality
  • Dietary Supplement: folic acid
    pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid
  • 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
  • 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 Name: UNIMMAP
  • Active Comparator: A, 1
    Intervention: Dietary Supplement: folic acid
  • Experimental: A, 2
    Intervention: Dietary Supplement: folic acid plus iron
  • Experimental: A, 3
    Multiple micronutrient supplement
    Intervention: Dietary Supplement: supplements with multiple vitamins and minerals
Liu JM, Mei Z, Ye R, Serdula MK, Ren A, Cogswell ME. Micronutrient supplementation and pregnancy outcomes: double-blind randomized controlled trial in China. JAMA Intern Med. 2013 Feb 25;173(4):276-82. doi: 10.1001/jamainternmed.2013.1632.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18962
December 2010
December 2009   (final data collection date for primary outcome measure)

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
Female
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00133744
CDC-NCCDPHP-4084
Yes
Zuguo Mei, Ceanters for Disease Control and Prevention
Centers for Disease Control and Prevention
Not Provided
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
Centers for Disease Control and Prevention
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP