Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dietary Supplements Iron Minerals Prenatal Care Stillbirth

Drug Information available for: Folic acid

U.S. FDA Resources

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: 20 weeks gestation to 6 days postpartum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	18962
Study Start Date:	May 2006
Study Completion Date:	December 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: UNIMMAP

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

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Zuguo Mei, Ceanters for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00133744 History of Changes
Other Study ID Numbers:	CDC-NCCDPHP-4084
Study First Received:	August 22, 2005
Last Updated:	March 18, 2011
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

Additional relevant MeSH terms:

Folic Acid
Hematinics
Iron
Micronutrients
Vitamins
Vitamin B Complex

Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on February 09, 2012