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Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality
This study is currently recruiting participants.
Verified by Centers for Disease Control and Prevention, September 2007
Sponsored by: Centers for Disease Control and Prevention
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00133744
  Purpose

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.


Condition Intervention Phase
Perinatal Mortality
Stillbirth
Neonatal Mortality
Dietary Supplement: folic acid
Dietary Supplement: folic acid plus iron
Dietary Supplement: supplements with multiple vitamins and minerals
Phase III

MedlinePlus related topics: Anemia Dietary Supplements Minerals Pregnancy Loss Prenatal Care
Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Iodine Cadexomer iodine Selenium Thiamine 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-m- ethylthiazolium chloride, monohydrochloride Niacin Niacin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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: 3.5 years from beginning of enrollment ]
  • Gastrointestinal side effects at monthly visits [ Time Frame: delivery of last infant in the study, 3.5 years ]

Secondary Outcome Measures:
  • 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 ages 6 and 12 months
  • Infant low weight-for-age at ages 6 and 12 months
  • Infant low height-for-age at ages 6 and 12 months
  • Infant anemia at ages 6 and 12 months

Estimated Enrollment: 23082
Study Start Date: May 2006
Estimated Study Completion Date: March 2010
Arms Assigned Interventions
A, 1: Active Comparator Dietary Supplement: folic acid
pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid
A, 2: Experimental 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
A, 3: Experimental
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

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).
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133744

Contacts
Contact: Mary E Cogswell, DrPH, RN 770-488-6053 MCogswell@cdc.gov
Contact: Mei Zuguo, MD, MPH 770-488-5864 ZMei@cdc.gov

Locations
China, Hebei
Laoting Maternal and Child Health Institute Recruiting
Laoting, Hebei, China, 063600
Contact: Lan Liu, MD, MPH     86-10-8280-1759     Liulan@ncmih.bjmu.edu.cn    
Fengrun Maternal and Child Health Institute Recruiting
Fengrun, Hebei, China, 064000
Contact: Wei Chang, MD     86-10-8280-1760 ext 108     Changwei@ncmih.bjmu.edu.cn    
Xianghe Maternal and Child Health Institute Recruiting
Xianghe, Hebei, China, 065400
Contact: Hui Zhang, MD     86-10-8280-1760 ext 115     Zhanghui@ncmih.bjmu.edu.cn    
Mancheng Maternal and Child Health Institute Recruiting
Mancheng, Hebei, China, 072150
Contact: Yinghui Liu, MD, PhD     86-10-8280-1760 ext 126     Liuyh@ncmih.bjmu.edu.cn    
Yuanshi Maternal and Child Health Institute Recruiting
Yuanshi, Hebei, China, 051130
Contact: Weihong Liu, MD, MPH     86-10-8280-1759     Liuwh@ncmih.bjmu.edu.cn    
Sponsors and Collaborators
Investigators
Principal Investigator: Zhu Li, MD, MPH National Center for Maternal and Infant Health, Peking University Health Science Center, Beijing China
Study Director: Jianmeng Liu, MD, PhD National Center for Maternal and Infant Health, Peking University Health Science Center, Beijing China
  More Information

Study ID Numbers: CDC-NCCDPHP-4084
Study First Received: August 22, 2005
Last Updated: September 20, 2007
ClinicalTrials.gov Identifier: NCT00133744  
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
pregnancy
vitamins
minerals
supplements
mortality
prenatal
perinatal
anemia
birthweight
preterm
iron
micronutrients
Stillbirths
Early neonatal deaths

Study placed in the following topic categories:
Birth Weight
Death
Hydroxocobalamin
Anemia
Thiamine
Vitamin B 12
Vitamin B 6
Folic Acid
Selenium
Nicotinic Acids
Iodine
Pyridoxine
Iron
Niacin

Additional relevant MeSH terms:
Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins
Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009