Effect of vitamin B12 fortified nutrient bar supplementation in Indian children

Completed

• Conditions: Improving vitamin status

• Registration Number: CTRI/2012/07/002799
• Lead Sponsor: Department of Biotechnology, Government of India

Brief Summary

This will be a double-blind, randomized, placebo-controlled trial having 3 groups (nutrient bar, nutrient bar fortified with vit B12, nutrient bar fortified with multiple micronutrients including vit B12). Each group will have 50 children (age 10-13y). The period of supplementation will be 5 months.

This sample size is sufficient to measure vitamin B12 rise of 100 pmol/L (SD 80) above the baseline, with power of 80% and 5% level of significance; and accounts for 5 drop outs per group. Appropriate ethical approval has been obtained from the EC, KEM Hospital Research Centre, Pune.

Data (height, weight and venous blood sample) will be collected at baseline and after 5 months.

*Data analysis:* We will compare biochemical parameters (hemoglobin, red cell indices, plasma vitamin B12) in the different groups.

The sample size, dose and duration of the trial is based on our previous experience of community based, double blind trial of vitamin B12 (crystalline) supplementation in capsule form (Deshmukh US et al). If vitamin B12 in fortified food form improves the circulating vitamin B12 status, it would provide a convincing mode for tackling widespread vitamin B12 insufficiency in our population.

**Reference:** Deshmukh US, Joglekar CV, Lubree HG, Ramdas LV, Bhat DS, Naik SS, Hardikar PS, Raut DA, Konde TB, Wills AK, Jackson AA, Refsum H, Nanivadekar AS, Fall CH, Yajnik CS. Effect of physiological doses of oral vitamin B12 on plasma homocysteine: a randomized, placebo-controlled, double-blind trial in India. Eur J Clin Nutr. 2010;64:495-502.

Progress of study

We screened 172 volunteers, they were briefed about the study and their consentsought. One hundred forty three consented to take part in the study. The subjects were screened for inclusion and exclusioncriteria. Twenty three volunteers were excluded due to low vitamin B12 concentrations(<100 pM/L) and 2 were excluded due to low haemoglobin concentrations (<7mg%). One hundred and eighteen were randomised into three groups. Theintervention started on 23rd December and was completed on 20thMay 2014.



**Conclusions:**

Crystalline B12 fortifiedyogurt improved B12 status while Propionibacetria fortified did not. Yogurt mayused as a vehicle for B12 supplementation in B12 deficient vegetarianpopulations and could be considered a component of midday school programmes.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-15
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

•Age between 10-13yrs •Willing to consent /assent and participate in the study.

Exclusion Criteria

•Plasma B12 concentration < 100 pmol/L •Hemoglobin < 10 g/ dL •Already taking supplements containing vitamin B12 for 10 or more days •On treatment with drugs known to impair the absorption or utilization of B12 (for example, phenytoin, antacids) •Medical conditions interfering with B12 absorption and utilization; chronic gastro-intestinal disease and worm infestations •Chronic illnesses preventing participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasma vitamin B12 concentrations	120 days (baseline and post-intervention)

Secondary Outcome Measures

Name	Time	Method
N/A	N/A

Trial Locations

Locations (1)

Diabetes Unit; 🇮🇳 Pune, MAHARASHTRA, India

Diabetes Unit

🇮🇳Pune, MAHARASHTRA, India

Prof Chittaranjan S Yajnik

Principal investigator

020-26111958

diabetes@vsnl.com