Use of special yoghurt to improve vitamin B12 status.

Completed

Conditions: Improving plasma vitamin status

Registration Number: CTRI/2015/04/005703

Lead Sponsor: Department of Biotechnology New Delhi

Brief Summary: This will be a double-blind, randomized, placebo-controlled trial having 3 groups (plain yoghurt, B12 fortified yoghurt, B12 producing probiotic fortified yoghurt). Each group will have ~40 adult volunteers (18-50y). 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 KEM Hospital Research Centre Ethics Comm ittee, Pune.

Data including Height, Weight, and venous blood sample will be collected at baseline and 5 months post intervention.

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 viamin B12 (crystalline) supplementation in capsule form (Deshmukh US et al). If 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

Age between 18-50yrs -Willing to consent and participate in the study.

Exclusion Criteria

Known allergy of milk and milk products -Severely B12 deficient (less than 100 pmol/L) -Anemia (Hemoglobin less than 7 g/ 100 ml) -Pregnant or lactating or planning for pregnancy in the study period -Already taking supplements containing vitamin B12 for 15 or more days -On treatment with drugs known to impair the absorption or utilization of B12 (eg phenytoin, antacids, metformin) -Medical conditions interfering with B12 absorption and utilization; chronic gastro-intestinal disease -Chronic illnesses preventing participation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasma vitamin B12 concentrations	baseline and 120 days 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 CS Yajnik
Principal investigator
02026111958
diabetes@kemdiabetes.org