Folic Acid and Vitamin B12 in Young Indian Children
Folic Acid and Vitamin B12 in Young Indian Children
NCT ID: NCT00717730 Phase: PHASE2 Status: COMPLETED Enrollment: 1000 Completion: 2011-09
Conditions
Diarrhea, Pneumonia
Interventions
Folic Acid, Vitamin B12, Placebo, Folic acid and vitamin B12
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.
Primary Outcome
Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia)