Clinical trial NCT05478291: Vitamin D Supplementation on Surrogate Markers of Atherosclerosis
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atherosclerosis
Keywords: Vitamin D
Prediabetes
Asian Indians
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A randomized open labelled placebo-controlled trial.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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)

Primary outcomes:
measure: Effects of vitamin D supplementation on structural of atherosclerosis
timeFrame: 2 .5 Years
measure: Effects of vitamin D supplementation on physiology of atherosclerosis
timeFrame: 2.5 Years
measure: Effects of vitamin D supplementation on biochemical profile of atherosclerosis
timeFrame: 2.5 Years
measure: Effects of vitamin D supplementation on physiology of atherosclerosis
timeFrame: 2.5 Years
Secondary outcomes:
Other outcomes:
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