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Folic Acid and Vitamin B12 in Young Indian Children

Information source: Centre For International Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diarrhea; Pneumonia

Intervention: Folic Acid (Dietary Supplement); Vitamin B12 (Dietary Supplement); Placebo (Dietary Supplement); Folic acid and vitamin B12 (Dietary Supplement)

Phase: Phase 2

Status: Completed

Sponsored by: Tor A. Strand

Official(s) and/or principal investigator(s):
Tor A Strand, MD, PhD, Principal Investigator, Affiliation: University of Bergen
Sunita Taneja, MBBS, PhD, Principal Investigator, Affiliation: Society for Essential Health Action and Training

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.

Clinical Details

Official title: Routine Administration of Folic Acid and Vitamin B12 to Prevent Childhood Infections in Young Indian Children

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia)

Prevalence of diarrhea

Secondary outcome:

Growth (length for age, weight for age, and length for weight)

Adverse events (vomiting and gastric discomfort)

Changes in folate, vitamin B12, methyl malonic acid, and homocysteine concentration

Developmental Milestones

Measure the association between pneumonia incidence and the plasma mannose binding lectin (MBL) concentration

Measure the exposure to Cryptosporidium spp

Measure the association between the antibody response to Cryptosporidium and plasma MBL

Compare the change in plasma MBL between the intervention groups

Vitamin D status

Vitamin D status and the risk for respiratory infections

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.

Eligibility

Minimum age: 6 Months. Maximum age: 30 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age: 6 to 30 months

- Either sex

- Likely to reside in area for next 6 months

Exclusion Criteria:

- Severe systemic illness requiring hospitalization

- Severe malnutrition, i. e. weight for height < -3 z of the WHO standard for this age

group. For ethical reasons these children require micronutrient supplementation and adequate medical care.

- Non consent

- Consuming vitamin supplements that include folic acid and vitamin B12.

- Severe anemia (Hb < 7 g/dL).

Locations and Contacts

Society for Essential Health Action and Training, New Delhi, Delhi, India
Additional Information

Related publications:

Taneja S, Bhandari N, Strand TA, Sommerfelt H, Refsum H, Ueland PM, Schneede J, Bahl R, Bhan MK. Cobalamin and folate status in infants and young children in a low-to-middle income community in India. Am J Clin Nutr. 2007 Nov;86(5):1302-9.

Strand TA, Taneja S, Bhandari N, Refsum H, Ueland PM, Gjessing HK, Bahl R, Schneede J, Bhan MK, Sommerfelt H. Folate, but not vitamin B-12 status, predicts respiratory morbidity in north Indian children. Am J Clin Nutr. 2007 Jul;86(1):139-44.

Allen LH. Multiple micronutrients in pregnancy and lactation: an overview. Am J Clin Nutr. 2005 May;81(5):1206S-1212S. Review.

Smith AD, Kim YI, Refsum H. Is folic acid good for everyone? Am J Clin Nutr. 2008 Mar;87(3):517-33.

Sazawal S, Dhingra U, Dhingra P, Hiremath G, Kumar J, Sarkar A, Menon VP, Black RE. Effects of fortified milk on morbidity in young children in north India: community based, randomised, double masked placebo controlled trial. BMJ. 2007 Jan 20;334(7585):140. Epub 2006 Nov 28.

Tielsch JM, Khatry SK, Stoltzfus RJ, Katz J, LeClerq SC, Adhikari R, Mullany LC, Shresta S, Black RE. Effect of routine prophylactic supplementation with iron and folic acid on preschool child mortality in southern Nepal: community-based, cluster-randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):144-52.

Fawzi WW, Msamanga GI, Spiegelman D, Urassa EJ, McGrath N, Mwakagile D, Antelman G, Mbise R, Herrera G, Kapiga S, Willett W, Hunter DJ. Randomised trial of effects of vitamin supplements on pregnancy outcomes and T cell counts in HIV-1-infected women in Tanzania. Lancet. 1998 May 16;351(9114):1477-82.

Sazawal S, Black RE, Ramsan M, Chwaya HM, Stoltzfus RJ, Dutta A, Dhingra U, Kabole I, Deb S, Othman MK, Kabole FM. Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):133-43. Erratum in: Lancet. 2006 Jan 28;367(9507):302.

Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007 Apr 5;356(14):1423-31.

Tamura T, Yoshimura Y, Arakawa T. Human milk folate and folate status in lactating mothers and their infants. Am J Clin Nutr. 1980 Feb;33(2):193-7.

Khambalia A, Latulippe ME, Campos C, Merlos C, Villalpando S, Picciano MF, O'connor DL. Milk folate secretion is not impaired during iron deficiency in humans. J Nutr. 2006 Oct;136(10):2617-24.

Starting date: January 2010
Last updated: July 27, 2015

Page last updated: August 23, 2015

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