vitamin d supplementation on surrogate markers of atherosclerosis

Conditions: Atherosclerosis

Summary: for this study, our sample population is individuals with prediabetes, who are at an increased risk for atherosclerosis. in this proposed randomized placebo-controlled prospective trial, we would be enrolling 120 subjects with prediabetes having vitamin d deficiency. these subjects will be randomized into two groups; lifestyle modification counselling along with intervention with either vitamin d supplementation or placebo. clinical and dietary profiles including sunlight exposure, anthropometry, glycemic and lipid profiles, fasting insulin, adiponectin, body composition (dexa), skinfolds (4 sites), surrogate markers of atherosclerosis/inflammation (tnf-alpha, hs-crp, matrix metalloproteinase-9, flow-mediated dilatation of brachial artery, pulse wave velocity, and carotid intima-mediated thickness) will be measured at week 0 and week.

prediabetes is a substantial problem in india not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of important for prevention of diabetes. it is not clear if vitamin d supplementation in indian population associated with heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dys-metabolic state etc. could, besides lifestyle factors, be related to vitamin d deficiency, or interaction between the two. this study is based on the assumption that the supplementation of vitamin d may decrease atherosclerosis in individuals with prediabetes. supplementation of vitamin d is of major significance in terms of economic and health benefits to the individual and to the country. in addition, such simple and low-cost measures would help maintain a normal metabolic system. the proposed study would also lead to a community-based model of education regarding metabolic and cardiovascular disease. this study will help to develop slandered protocol for the prevention and treatment of non-communicable diseases (ncds). in india, the prevalence of coronary heart disease (7%-13% in urban and 2%-7% in rural populations), as well as diabetes, is high. positive results from this study may benefit a large number of individuals at risk for cardiovascular disease. in addition, if vitamin d supplementation leads to decreased atherosclerosis as indicated by surrogate markers of atherosclerosis, it may be a cost-effective and novel way to reduce or prevent atherosclerosis in the indian population, which is at high risk for the development of atherosclerosis.

Eligibility criteria:
inclusion criteria: * pre-diabetes: fasting blood glucose ≥100mg/dl and \<125.99mg/dl, 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 g anhydrous oral glucose). * baseline level of 25 hydroxy vitamin d \<30ng/dl and aged 20-60 years. exclusion criteria: * received vitamin d and/or calcium supplementation in the previous six months, on any medication within the last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin d or calcium metabolism (eg metformin, thiazolidione, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steriods, calcitonin etc.) * severe end-organ damage, any malignancy, nephrotic syndrome, malabsorption etc, * known case of hiv infection, hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis)

Keywords: vitamin d prediabetes asian indians