Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

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.
    

Intervention name(s): Vitamin B Complex and Folic Acid; Iron and Folic Acid; Folic Acid
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; Daily oral dose of 60 mg iron and 0.4 mg folic acid.; Daily oral dose of 0.4 mg folic acid.
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention