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Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease

NCT02537392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7315

Last updated 2020-07-08

No results posted yet for this study

Summary

The purpose of this study is to determine whether daily oral supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid given to women during peri-conception can reduce the risk of congenital heart disease when compared with folic acid alone.

Conditions

  • Congenital Heart Disease

Interventions

DIETARY_SUPPLEMENT

Vitamin B Complex and Folic Acid

Daily oral dose containing 2 mg vitamin B1, 2 mg vitamin B2, 2 mg vitamin B6, 2 μg vitamin B12, 2 mg calcium pantothenate, 15 mg nicotinamide and 0.4 mg folic acid.

DIETARY_SUPPLEMENT

Iron and Folic Acid

Daily oral dose of 60 mg iron and 0.4 mg folic acid.

DIETARY_SUPPLEMENT

Folic Acid

Daily oral dose of 0.4 mg folic acid.

Sponsors & Collaborators

  • Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Hong Yan, Professor · Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02537392 on ClinicalTrials.gov