Vitamin D Supplementation on Surrogate Markers of Atherosclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorDiabetes Foundation, India

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Treatments tested in this trial

  • Vitamin D supplementation

Treatment groups

120 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators