NCT00133744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,962

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2006

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 21, 2011

Status Verified

March 1, 2011

Enrollment Period

3.6 years

First QC Date

August 22, 2005

Last Update Submit

March 18, 2011

Conditions

Perinatal MortalityStillbirthNeonatal Mortality

Keywords

pregnancyvitaminsmineralssupplementsmortalityprenatalperinatalanemiabirthweightpretermironmicronutrientsStillbirthsEarly neonatal deaths

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Maternal anemia

    24-28 weeks gestation

  • Maternal anemia

    4-8 weeks postpartum

  • Infant gestational age at birth, preterm delivery

    delivery

  • Infant birth weight, low birth weight

    at birth

  • Infant low weight-for-height

    infant age 6 months and 12 months

  • +2 more secondary outcomes

Study Arms (3)

A, 1

ACTIVE COMPARATOR
Dietary Supplement: folic acid

A, 2

EXPERIMENTAL
Dietary Supplement: folic acid plus iron

A, 3

EXPERIMENTAL

Multiple micronutrient supplement

Dietary Supplement: supplements with multiple vitamins and minerals

Interventions

folic acidDIETARY_SUPPLEMENT

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

A, 1
folic acid plus ironDIETARY_SUPPLEMENT

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

A, 2
supplements with multiple vitamins and mineralsDIETARY_SUPPLEMENT

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

Also known as: UNIMMAP
A, 3

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Live in one of the study counties (Laoting, Mancheng, Fengrun, Xianghe, Yuanshi)
  • Can follow instructions
  • Can swallow pills

You may not qualify if:

  • \>= 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fengrun Maternal and Child Health Institute

Fengrun, Hebei, 064000, China

Location

Yuanshi Maternal and Child Health Institute

Huaiyang, Hebei, 051130, China

Location

Laoting Maternal and Child Health Institute

Laoting, Hebei, 063600, China

Location

Mancheng Maternal and Child Health Institute

Mancheng, Hebei, 072150, China

Location

Xianghe Maternal and Child Health Institute

Xianghe, Hebei, 065400, China

Location

Related Publications (5)

  • 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.

    PMID: 35265334DERIVED

  • 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.

    PMID: 33594802DERIVED

  • 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.

    PMID: 29428785DERIVED

  • 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.

    PMID: 27263403DERIVED

  • 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.

    PMID: 23303315DERIVED

MeSH Terms

Conditions

Perinatal DeathStillbirthAnemiaBirth WeightPremature Birth

Interventions

Folic AcidIronGeritolMinerals

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsFetal DeathHematologic DiseasesHemic and Lymphatic DiseasesBody WeightSigns and SymptomsObstetric Labor, PrematureObstetric Labor Complications

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Weicheng You, MD, MBA

    Peking University Health Science Center, Beijing China

    PRINCIPAL INVESTIGATOR

  • Jianmeng Liu, MD, PhD

    Institute of Reproductive and Child Health, Peking University Health Science Center, Beijing China

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

May 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

March 21, 2011

Record last verified: 2011-03

Locations

CN(5)