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Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

Primary Purpose

Perinatal Mortality, Stillbirth, Neonatal Mortality

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
folic acid
folic acid plus iron
supplements with multiple vitamins and minerals
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal Mortality focused on measuring pregnancy, vitamins, minerals, supplements, mortality, prenatal, perinatal, anemia, birthweight, preterm, iron, micronutrients, Stillbirths, Early neonatal deaths

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Fengrun Maternal and Child Health Institute
  • Laoting Maternal and Child Health Institute
  • Mancheng Maternal and Child Health Institute
  • Xianghe Maternal and Child Health Institute
  • Yuanshi Maternal and Child Health Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A, 1

A, 2

A, 3

Arm Description

Multiple micronutrient supplement

Outcomes

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)

Secondary Outcome Measures

Maternal anemia
Maternal anemia
Infant gestational age at birth, preterm delivery
Infant birth weight, low birth weight
Infant low weight-for-height
Infant anemia
maternal gastrointestinal side effects

Full Information

First Posted
August 22, 2005
Last Updated
March 18, 2011
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00133744
Brief Title
Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Mortality, Stillbirth, Neonatal Mortality
Keywords
pregnancy, vitamins, minerals, supplements, mortality, prenatal, perinatal, anemia, birthweight, preterm, iron, micronutrients, Stillbirths, Early neonatal deaths

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18962 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A, 1
Arm Type
Active Comparator
Arm Title
A, 2
Arm Type
Experimental
Arm Title
A, 3
Arm Type
Experimental
Arm Description
Multiple micronutrient supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
folic acid
Intervention Description
pills by mouth, one per day, from the first prenatal visit until delivery, 400 micrograms (mcg) folic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
folic acid plus iron
Intervention Description
pills by mouth, one per day, from the first prenatal visit until delivery, 400 mcg folic acid, 30 mg Fe
Intervention Type
Dietary Supplement
Intervention Name(s)
supplements with multiple vitamins and minerals
Other Intervention Name(s)
UNIMMAP
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Maternal anemia
Time Frame
24-28 weeks gestation
Title
Maternal anemia
Time Frame
4-8 weeks postpartum
Title
Infant gestational age at birth, preterm delivery
Time Frame
delivery
Title
Infant birth weight, low birth weight
Time Frame
at birth
Title
Infant low weight-for-height
Time Frame
infant age 6 months and 12 months
Title
Infant anemia
Time Frame
6 months and 12 months of age
Title
maternal gastrointestinal side effects
Time Frame
monthly from a month after enrollment until delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weicheng You, MD, MBA
Organizational Affiliation
Peking University Health Science Center, Beijing China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianmeng Liu, MD, PhD
Organizational Affiliation
Institute of Reproductive and Child Health, Peking University Health Science Center, Beijing China
Official's Role
Study Director
Facility Information:
Facility Name
Fengrun Maternal and Child Health Institute
City
Fengrun
State/Province
Hebei
ZIP/Postal Code
064000
Country
China
Facility Name
Laoting Maternal and Child Health Institute
City
Laoting
State/Province
Hebei
ZIP/Postal Code
063600
Country
China
Facility Name
Mancheng Maternal and Child Health Institute
City
Mancheng
State/Province
Hebei
ZIP/Postal Code
072150
Country
China
Facility Name
Xianghe Maternal and Child Health Institute
City
Xianghe
State/Province
Hebei
ZIP/Postal Code
065400
Country
China
Facility Name
Yuanshi Maternal and Child Health Institute
City
Yuanshi
State/Province
Hebei
ZIP/Postal Code
051130
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35265334
Citation
Si KY, Li HT, Zhou YB, Li ZW, Zhang L, Zhang YL, Ye RW, Liu JM. Cesarean delivery on maternal request and common child health outcomes: A prospective cohort study in China. J Glob Health. 2022 Feb 26;12:11001. doi: 10.7189/jogh.12.11001. eCollection 2022.
Results Reference
derived
PubMed Identifier
33594802
Citation
Liu Y, Li N, Mei Z, Li Z, Ye R, Zhang L, Li H, Zhang Y, Liu JM, Serdula MK. Effects of prenatal micronutrients supplementation timing on pregnancy-induced hypertension: Secondary analysis of a double-blind randomized controlled trial. Matern Child Nutr. 2021 Jul;17(3):e13157. doi: 10.1111/mcn.13157. Epub 2021 Feb 16.
Results Reference
derived
PubMed Identifier
29428785
Citation
Chen S, Li N, Mei Z, Ye R, Li Z, Liu J, Serdula MK. Micronutrient supplementation during pregnancy and the risk of pregnancy-induced hypertension: A randomized clinical trial. Clin Nutr. 2019 Feb;38(1):146-151. doi: 10.1016/j.clnu.2018.01.029. Epub 2018 Feb 15.
Results Reference
derived
PubMed Identifier
27263403
Citation
Zhang Y, Jin L, Liu JM, Ye R, Ren A. Maternal Hemoglobin Concentration during Gestation and Risk of Anemia in Infancy: Secondary Analysis of a Randomized Controlled Trial. J Pediatr. 2016 Aug;175:106-110.e2. doi: 10.1016/j.jpeds.2016.05.011. Epub 2016 Jun 2.
Results Reference
derived
PubMed Identifier
23303315
Citation
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.
Results Reference
derived

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Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

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