Folic Acid and Vitamin B12 in Young Indian Children

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.

Conditions

• Diarrhea
• Pneumonia

Interventions

DIETARY_SUPPLEMENT

Folic Acid

150µgm/day for 6 months in children older than 11 months and 80µgm in 6 to 11 months.

DIETARY_SUPPLEMENT

Vitamin B12

1.8µgm/day for 6 months in children older than 11 months and 0.5µgm in 6 to 11 months.

DIETARY_SUPPLEMENT

Placebo

Placebo with no active ingredients

DIETARY_SUPPLEMENT

Folic acid and vitamin B12

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.

Sponsors & Collaborators

• Society for Essential Health Action and Training, New Delhi, India

  collaborator UNKNOWN

• Thrasher Research Fund

  collaborator OTHER

• Tor A. Strand

  lead OTHER

Principal Investigators

• Tor A Strand, MD, PhD · University of Bergen

• Sunita Taneja, MBBS, PhD · Society for Essential Health Action and Training

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

6 Months

Max Age

30 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• India

Study Locations