AtherosclerosisNCT05478291
Vitamin D Supplementation on Surrogate Markers of Atherosclerosis
A study testing Vitamin D supplementation in people with Atherosclerosis, run by Diabetes Foundation, India.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Vitamin D supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Vitamin D supplementation
- Keywords
- Vitamin D, Prediabetes, Asian Indians
- Medical subject headings
- Atherosclerosis, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2.5 Years
Effects of vitamin D supplementation on biochemical profile of atherosclerosis
Biochemical: TNF-alpha, hs-CRP, Matrix Metalloproteinase-9.
Measured: 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.
Measured: 2.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Sep 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A randomized open labelled placebo-controlled trial.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478291
- Sponsor's protocol ID
- 2021-8753
- Status last verified
- Jun 2023
- First submitted
- 27 Apr 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will be conducted at the outpatient department of National Diabetes, Obesity and Cholesterol Foundation (N-DOC), Diabetes Foundation (India) (DFI) and Fortis-C-DOC, Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05478291
- Acronym / sponsor ID
- 2021-8753
- Conditions
- Atherosclerosis
- Keywords
- Vitamin D, Prediabetes, Asian Indians
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A randomized open labelled placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation | Experimental | Other: Vitamin D supplementationAppropriate 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplementationAppropriate 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. | Other | Vitamin D supplementation |
Primary outcome
Effects of vitamin D supplementation on structural of atherosclerosis
Time frame: 2 .5 Years
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.
Effects of vitamin D supplementation on physiology of atherosclerosis
Time frame: 2.5 Years
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.
Effects of vitamin D supplementation on biochemical profile of atherosclerosis
Time frame: 2.5 Years
Biochemical: TNF-alpha, hs-CRP, Matrix Metalloproteinase-9.
Effects of vitamin D supplementation on physiology of atherosclerosis
Time frame: 2.5 Years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No. This study will be conducted at the outpatient department of National Diabetes, Obesity and Cholesterol Foundation (N-DOC), Diabetes Foundation (India) (DFI) and Fortis-C-DOC, Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplementation in people with Atherosclerosis, run by Diabetes Foundation, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, MD (01141759672, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of vitamin D supplementation on structural of atherosclerosis (time frame: 2 .5 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.