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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00133744
Enrollment
18962
Registered
2005-08-24
Start date
2006-05-31
Completion date
2010-12-31
Last updated
2011-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Mortality, Perinatal Mortality, Stillbirth

Keywords

pregnancy, vitamins, minerals, supplements, mortality, prenatal, perinatal, anemia, birthweight, preterm, iron, micronutrients, Stillbirths, Early neonatal deaths

Brief 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.

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).

Interventions

DIETARY_SUPPLEMENTfolic acid

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

DIETARY_SUPPLEMENTfolic acid plus iron

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

DIETARY_SUPPLEMENTsupplements 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

Sponsors

Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Infant gestational age at birth, preterm deliverydelivery
Infant birth weight, low birth weightat birth
Maternal anemia24-28 weeks gestation
Infant anemia6 months and 12 months of age
maternal gastrointestinal side effectsmonthly from a month after enrollment until delivery
Infant low weight-for-heightinfant age 6 months and 12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026