At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Routine Administration of Folic Acid and Vitamin B12 to Prevent Childhood Infections in Young Indian Children
In Brief
A Phase 2 clinical trial evaluating Folic Acid, Vitamin B12, and 2 other interventions for Diarrhea and Pneumonia. Completed, enrolled 1,000 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.