NCT02537392

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

Primary Prevention of Multi-micronutrient Supplementation During Peri-conception Against Congenital Heart Disease: A Community-based Randomised Controlled Trial in China

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7,315 (actual)
• Sponsor: Xi'an Jiaotong University · Academic / Other
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-09-01
• Last updated: 2020-07-08

Locations

1 site across 1 country: China