Vitamin D Supplementation on Surrogate Markers of Atherosclerosis

NCT05478291 | Not Yet Recruiting

• 1 other identifier: 2021-8753
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atherosclerosis

Keywords

Vitamin D; Prediabetes; Asian Indians

Outcome Measures

Primary Outcomes (4)

• Effects of vitamin D supplementation on structural of atherosclerosis

  Carotid intima media thickness (CIMT) will be measured using a high resolution B-mode ultrasound machine equipped with an 11-MHz frequency linear probe, the procedure will be done by the same radiologist on the same ultrasound machine. All subjects (patients and control) will be examined in supine position, neck extended and chin facing the contralateral side, both common carotid arteries will be examined in both longitudinal and transverse scans, three consecutive measurements of intima media thickness will be taken from the far wall of both common carotid arteries, 1-2 cm proximal to the carotid bulb over the common carotid artery and in the proximal most portion of the internal carotid artery near its origin and the average of these 6 measurements from both sides will taken for final statistical analysis.

  2 .5 Years

• Effects of vitamin D supplementation on physiology of atherosclerosis

  Brachial artery ultrasound study will be performed in a quiet, dark, temperature-controlled room, all the participants will be in supine position, resting for 10 min, and the measurements of brachial artery will be taken in longitudinal scan in the arm 5-10 cm above the antecubital fossa without permanent vascular access. The luminal diameter of the artery will be measured between the proximal and distal intima.

  2.5 Years

• Effects of vitamin D supplementation on biochemical profile of atherosclerosis

  Biochemical: TNF-alpha, hs-CRP, Matrix Metalloproteinase-9.

  2.5 Years

• Effects of vitamin D supplementation on physiology of atherosclerosis

  Pulse wave analysis: Using a Mobil-O-Graph (I.E.M., Stolberg, Germany), we will perform pulse wave analyses. The individuals will be performed during the time of pulse wave analysis four BP measurements. The determination of heart rate, peripheral and central pulse pressure, and arterial stiffness of Mobil-O-Graph PWV, also called oPWV, followed all Expert Consensus Document's recommendations on the measurement of Aortic Stiffness 2012.

  2.5 Years

Study Arms (1)

Vitamin D supplementation

EXPERIMENTAL

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.

Other: Vitamin D supplementation

Interventions

Vitamin D supplementation OTHER

Appropriate diet and physical activity counselling to both groups. Supplementation with Vitamin D and oral Calcium-Doses of cholecalciferol (commercial name, Calcirol) 60,000 IU (sachets, dissolved in half glass milk) once per week for eight weeks for the 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 IU per day will be given as a maintenance dose. Equal doses of calcium carbonate (1gm per day, commercial name Calcal) will be given to both the groups.

Vitamin D supplementation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Diabetes Foundation, India: lead

MeSH Terms

Conditions

Atherosclerosis; Prediabetic State

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Anoop Misra, MD

CONTACT

01141759672; anoopmisra@gmail.com

SURYA PRAKASH, PhD

CONTACT

09810085720; suryabhat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Both participants and their clinical care team will be aware of the allocation.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Model Details: A randomized open labelled placebo-controlled trial.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: July 28, 2022
• Study Start: September 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share