Vitamin D Supplementation on Surrogate Markers of Atherosclerosis

Atherosclerosis Clinical Trial

Official title: Effect of Vitamin D Supplementation on Surrogate Markers of Atherosclerosis in North Indian Individuals With Pre-diabetes and Low Vitamin D Levels: a Randomised Controlled Trial.

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Atherosclerosis

• NCT number: NCT05478291
• Study type: Interventional
• Source: Diabetes Foundation, India
• Contact: Anoop Misra, MD
• Phone: 01141759672
• Email: anoopmisra@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Completion date: August 30, 2026