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

NCT ID: NCT02537392

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-12-31

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.

Detailed Description

Congenital heart disease (CHD) is among the most prevalent congenital abnormalities with an incidence of about 8-12/1,000 live births, and is also the leading cause of infant morbidity and death from birth defects. A series of studies pointed out that the poor nutritional status of the mother during peri-conception might be the important cause of CHD. In maternal folic acid/ vitamin B deficiency homocysteine accumulates in the serum, and elevated circulating homocysteine concentrations have been associated with the risk of CHD. However, it is still questionable whether multiple vitamin B supplements during peri-conception can reduce CHD risk more effectively compared with the supplement of folic acid alone. Moreover, one randomized controlled trial performed in Shaanxi China confirmed that the supplement of iron and folic acid during pregnancy can significantly reduce early neonatal deaths. It is noteworthy that one-fourth of newborn deaths are attributable to birth defects. Thus, it is worthwhile to investigate whether iron supplement can reduce the risk of CHD.

This community-based randomized controlled trial will assess and compare the impact of daily oral supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid vs. folic acid alone given to women during peri-conception on CHD. It will also assess the effects of the three different supplementations on other pregnancy outcomes and maternal health. The study will be conducted in three rural poor counties including Xunyi, Changwu, and Bin, which are located in Shaanxi Province of Northwest China. All participants will sign informed consent before the study. The investigators hypothesize that the newborn infants of women receiving supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid will experience a reduction in the prevalence of infants with the pulse oxygen saturation less than 95% and other adverse pregnancy outcomes compared with those receiving folic acid alone. The results of this trial will provide evidence needed to formulate policy on maternal micronutrient supplementation during peri-conception and the rationale for the necessary investment of public funds to implement appropriate programs against birth defects.

Conditions

Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitamin B Complex and Folic Acid

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).

Group Type: EXPERIMENTAL

Vitamin B Complex and Folic Acid

Intervention Type: 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.

Iron and Folic Acid

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

Group Type: EXPERIMENTAL

Iron and Folic Acid

Intervention Type: DIETARY_SUPPLEMENT

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

Folic Acid

Daily supplement of 0.4 mg folic acid.

Group Type: ACTIVE_COMPARATOR

Folic Acid

Intervention Type: DIETARY_SUPPLEMENT

Daily oral dose of 0.4 mg folic acid.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Iron and Folic Acid

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

Intervention Type: DIETARY_SUPPLEMENT

Folic Acid

Daily oral dose of 0.4 mg folic acid.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Women of reproductive age (15-49 years) who reside in the study areas;

2. Women who are prepared for pregnancy in 1-3 months or have already been pregnant for less than 20 months;

3. Women who have provided written informed consent.

Exclusion Criteria

1. Women who have already taken supplements containing vitamin B complex, iron, or folic acid for more than two weeks at enrollment;

2. Women who have given birth to children with congenital heart disease or other birth defects before;

3. Women with diabetes;

4. women with severe heart, liver or kidney disease.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Jiaomei Yang

PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Yan, Professor

Role: PRINCIPAL_INVESTIGATOR

Xi'an Jiaotong University

Locations

Xi'an Jiaotong University College of Medicine

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31056148 (View on PubMed)

Other Identifiers

NSFC81230016

Identifier Type: -

Identifier Source: org_study_id