Folic Acid and Vitamin B12 in Young Indian Children
Condition: Diarrhea; Pneumonia
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or
      without simultaneous administration of vitamin B12 reduces the rates of acute lower
      respiratory tract infections (ALRI), clinical pneumonia and diarrhea.

      Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of
      folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a
      low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months
      will be identified through a survey. Eligible and willing Children aged 6-30 months will be
      randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by
      the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child
      weight and length taken. The baseline blood samples will be collected. The supplements will
      be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by
      field workers.
    

Detailed description: 
      Pneumonia and diarrhea are among the leading causes of poor health and death in young
      children of developing countries.

      Many of these children have inadequate intakes of several vitamins and minerals. Folate and
      vitamin B12 are important for normal function of the immune system. Deficiencies of these
      vitamins are often part of general malnutrition and might be responsible for the excess
      morbidity and mortality seen in malnourished children. In a recent cohort study in almost
      2,500 Indian children we demonstrated that those with poor folate status had higher rates of
      diarrhea and pneumonia. This study also showed that children that were not breastfed had poor
      folate status and our analyses suggested that the effect of breastfeeding in preventing
      respiratory and gastrointestinal infections could be explained by the folate content of
      breast milk. The finding that poor folate status is related to increased susceptibility to
      childhood infections needs to be confirmed in well conducted clinical trials in populations
      where folate deficiency is prevalent.

      This trial aims to examine whether daily supplementation of 2 recommended doses of folate or
      vitamin B12 or both will lessen the incidence of acute lower respiratory tract infections and
      diarrhea. We will also measure if the supplementation improves the weight and length of
      supplemented children.
    

Intervention name(s): Folic Acid; Vitamin B12; Placebo; Folic acid and vitamin B12
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months.; 1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months.; Placebo with no active ingredients; Folic acid 150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months vitamin B12 1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months.
Other intervention name(s): Folate; Cobalamin
Intervention MeSH terms: Vitamins; Folic Acid; Hydroxocobalamin; Vitamin B 12; Vitamin B Complex
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nutrition; Children; Folate; Vitamin B12; India; Homocysteine; Methyl Malonic Acid