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

NCT02537392 | Completed DMC

• 1 other identifier: NSFC81230016
• Study Type: interventional
• Target: 7,315
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Neonatal pulse oximetry oxygen saturation measured by pulse oximetry

  Neonatal pulse oximetry oxygen saturation (SpO2) is tested by pulse oximetry in babies aged between 6 h and 72 h after birth. Pulse oximetry testing is repeated 4 h later if the first measurement is between 90% and 95%. The result of SpO2 will be reported as a dichotomous variable, in which the result is deemed positive if an SpO2 less than 95% is obtained both on the right hand and on either foot on two measures, separated by 4 h; a difference between the two extremities was more than 3% on two measures, separated by 4 h; or any measure is less than 90%. The result of SpO2 will also be reported as a continuous variable.

  6-72 hours after delivery

Secondary Outcomes (11)

• Incidence of congenital heart disease and the subtypes

  Half a year after delivery

• Incidence of birth defects and the subtypes

  Half a year after delivery

• Birth weight measured by baby scale

  Within 1 hours of delivery

• Incidence of low birth weight

  Within 1 hour of delivery

• Gestational age at birth

  At delivery

Study Arms (3)

Vitamin B Complex and Folic Acid

EXPERIMENTAL

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

Dietary Supplement: Vitamin B Complex and Folic Acid

Iron and Folic Acid

EXPERIMENTAL

Daily supplements of iron (60 mg) and folic acid (0.4 mg).

Dietary Supplement: Iron and Folic Acid

Folic Acid

ACTIVE COMPARATOR

Daily supplement of 0.4 mg folic acid.

Dietary Supplement: Folic Acid

Interventions

Vitamin B Complex and Folic Acid DIETARY_SUPPLEMENT

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.

Vitamin B Complex and Folic Acid

Iron and Folic Acid DIETARY_SUPPLEMENT

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

Iron and Folic Acid

Folic Acid DIETARY_SUPPLEMENT

Daily oral dose of 0.4 mg folic acid.

Folic Acid

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women of reproductive age (15-49 years) who reside in the study areas;
• Women who are prepared for pregnancy in 1-3 months or have already been pregnant for less than 20 months;
• Women who have provided written informed consent.

You may not qualify if:

• Women who have already taken supplements containing vitamin B complex, iron, or folic acid for more than two weeks at enrollment;
• Women who have given birth to children with congenital heart disease or other birth defects before;
• Women with diabetes;
• women with severe heart, liver or kidney disease.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

Xi'an Jiaotong University College of Medicine

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• Mi B, Wen X, Li S, Liu D, Lei F, Liu R, Shen Y, Chen Y, Zeng L, Liu X, Dang S, Yan H. Vegetable dietary pattern associated with low risk of preeclampsia possibly through reducing proteinuria. Pregnancy Hypertens. 2019 Apr;16:131-138. doi: 10.1016/j.preghy.2019.04.001. Epub 2019 Apr 8.

  PMID: 31056148 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Vitamin B Complex; Folic Acid; Iron

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Hong Yan, Professor

  Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)