Vitamin B 12 deficiency is widely prevalent in Indian population. Low vitamin B 12 status has been associated with low birth weight, congenital malformations like neural tube defects (NTD), adiposity, insulin resistance (IR), cardiovascular disease (CVD), and poor cognitive performance. Hyperhomocysteinemia, one of the biochemical markers of vitamin B 12 deficiency is associated with cardiovascular morbidity, dementia and osteoporosis. Our previous proof-of- principle trials have established that oral vitamin B 12 absorption is normal in most of the population and supplementation of vitamin B 12 over short term, in high doses, as well as over long term, in physiological doses (2 and 10 µg/ day) is effective in reducing plasma homocysteine.
Very few studies in India have shown efficacy of foods fortified with vitamin B 12 (along with other micronutrients) in improving its circulating status. We hypothesize that vitamin B 12 given alone or with other micronutrients, in fortified food or probiotic yoghurt/milk form in physiological dose is effective in improving the circulating B 12 status .
To test the hypotheses that, daily supplementation with 100 ml of vitamin B 12 producing probiotic fortified yogurt is effective in increasing circulating vitamin B 12 status .
Methodology and Design
This will be a double-blind, randomized, placebo-controlled trial. The intervention groups will include 1) vitamin B 12 producing probiotic fortified yogurt 2) Vitamin B 12 fortified yoghurt and 3) Plain Yoghurt. Each group will have 40 adult volunteers. The period of supplementation will be 120 days. This sample size is sufficient to measure vitamin B 12 rise of 100 pmol/L above the baseline, with power of 80% at 5% level of significance (assuming 5 drop outs per group). Appropriate ethical approval has been obtained from the Ethics Committee of the KEM Hospital Research Centre, Pune for the study.
We will measure height, weight and blood parameters (haemoglobin, red cell indices, plasma vitamin B 12 ) at baseline and after 120 days of intervention .
The original grant from the DBT did not cover the cost of the probiotic yogurt which was to be provided by the National Dairy Research Institute (NDRI) free of cost for research purposes. As NDRI were unable to provide the yogurt due to logistical reasons, we were required to source a suitable local vendor who would be able to manufacture the product using NDRI culture. We requested additional funding from DBT at the annual review meeting of the project and the costs for the yogurt have been approved; we have received the formal letter from DBT in February 2013. Financial support was received in April 2013.
Preparation of the case record forms was completed and the IRB approval was obtained in October 2012. Training of staff and standardisation of various techniques is ongoing. CRF's have been finalised. We have handed over the cultures to the manufacturing agency and will commence the project once the product (yoghurt) is tested for its palatability, vitamin content and quality. Volunteers will be briefed about the study and their consent sought. Screening will commence thereafter (last week of June).