Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

Stillbirth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133744
• Other study ID #: CDC-NCCDPHP-4084
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: March 18, 2011
• Start date: May 2006
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18962
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neonatal Mortality
• Perinatal Mortality
• Stillbirth

Intervention

Dietary Supplement:
• folic acid
pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid
• folic acid plus iron
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
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

Locations

Country	Name	City	State
China	Fengrun Maternal and Child Health Institute	Fengrun	Hebei
China	Laoting Maternal and Child Health Institute	Laoting	Hebei
China	Mancheng Maternal and Child Health Institute	Mancheng	Hebei
China	Xianghe Maternal and Child Health Institute	Xianghe	Hebei
China	Yuanshi Maternal and Child Health Institute	Yuanshi	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		20 weeks gestation to 6 days postpartum	Yes
Secondary	Maternal anemia		24-28 weeks gestation	No
Secondary	Maternal anemia		4-8 weeks postpartum	No
Secondary	Infant gestational age at birth, preterm delivery		delivery	No
Secondary	Infant birth weight, low birth weight		at birth	No
Secondary	Infant low weight-for-height		infant age 6 months and 12 months	No
Secondary	Infant anemia		6 months and 12 months of age	No
Secondary	maternal gastrointestinal side effects		monthly from a month after enrollment until delivery	Yes