Vitamin D Supplementation on Surrogate Markers of Atherosclerosis

Diabetes Foundation, India

Status: Not yet enrolling

Conditions: Atherosclerosis

Treatments: Other: Vitamin D supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05478291

2021-8753

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Vitamin D supplementation

Experimental group

Description:

Appropriate diet and physical activity counselling Supplementation with Vitamin D and oral Calcium- Doses of cholecalciferol (commercial name, Calcirol) 60,000 international units (sachets, dissolved in half glass milk) once per week for eight weeks to intervention group and placebo (Lactose granules) to the placebo group according to the random numbers generated by the computer. After every 24 weeks blood 25 (OH) D levels will be assessed. If the subjects are found to be still deficient then supplementation of cholecalciferol 60,000 IU per week for eight weeks will be repeated. If the 25 (OH) D levels are normal, then cholecalciferol supplementation in doses of 200 international units per day will be given as a maintenance dose.

Treatment:

Other: Vitamin D supplementation