Vitamin D SupplementationNCT04025489
Vitamin D Supplementation on Surrogate Markers of Ageing, Ageing Genes, Glycemic and Metabolic Markers in North India
A study of Vitamin D Supplementation and PreDiabetes, run by Diabetes Foundation, India at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Supplementation, PreDiabetes, Aging
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2020to 30 Mar 2024
- 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, or
- 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 g anhydrous oral glucose), and
- Baseline blood level of 25 hydroxy vitamin D <30ng/dl.
- Aged 20-60 years
Who cannot join
- Received Vitamin D or calcium supplementation in the previous six months.
- On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism and on any medication that activate steroid and xenobiotic receptors, and drugs used in transplantation.
- Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
- Known case of diabetes mellitus, HIV infection and other endocrine disorders.
- Prospective Intervention Study:
- Design: Randomized open labeled placebo-controlled trial.
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- Received Vitamin D and/or calcium supplementation in the previous six months.
- On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. metformin, thiazolidinediones, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steroids, calcitonin etc.)
- Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc.
- Known case of HIV infection.
- Primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas.
- Known case of diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology
Delhi
Anoop Misra, MD
About this study
Official title: Randomized Control Trial of Vitamin D Supplementation on Surrogate Markers of Ageing, Association/Interactions With Selected Ageing-related Genes, Glycemic and Metabolic Markers in North Indian Individuals With the Prediabetes
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 apparent accelerated aging 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 ageing-related genes, or interaction between the two. This study is based on the assumption that the supplementation of vitamin d could lead to reversal to normal glucose regulation and may slow aging process in individuals with pre-diabetes.
Read the detailed description
Asian Indians develop metabolic syndrome and diabetes earlier than in most population. In other words, Asian Indians have all the risk factors which may predispose to accelerated ageing; insulin resistance, dysglycemia, subclinical inflammation, and vasculopathy.
Vitamin D deficiency is widespread in both urban and rural populations of India. It is possible that vitamin D may also act on pathway related to aging which also are common to chronic diseases like diabetes. In this respect the surrogate markers of ageing (leukocyte telomerase length and telomerase activity) could be affected if vitamin D deficiency occurs. While some studies have shown relationship between vitamin D supplementation and leukocyte telomerase length in other populations, such study has not been systematically performed in Asian Indians. In this context, it is also not clear if some proposed genes of ageing may have some influence of development of prediabetes or diabetes and may interact with vitamin D. One of the candidate gene MSTN, according to our previous study, showed close correlation with excess body fat and decrease muscle mass, body composition characteristics conducive to development of diabetes. Additionally, deficiency of vitamin D could be linked to insulin resistance, prediabetes, though these issues have been debated. Some studies suggest that vitamin D supplementation may improve insulin sensitivity in Asian Indians. A research focusing on relationship of vitamin D supplementation with pro-ageing metabolic factors (glycemia, insulin resistance etc,), ageing related genes and surrogate markers of ageing is needed.
This study has two components; cross-sectional and prospective. Cross-sectional study will be of 2 years duration where 500 subjects from urban area of Delhi will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure. The population will be representative of different socio-economic strata of the society. In this, vitamin D levels, leukocyte telomerase length and telomerase activity in peripheral blood leukocytes, telomerase activity and single nucleotide polymorphisms [ACTN3, VDR, FOXO3A, SIRT1 and MSTN] in prediabetes Asian Indians.
Second part consists of open-label randomized placebo-controlled prospective trial, in which the investigators would be enrolling 200 prediabetic subjects with vitamin D deficiency. These subjects will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. Anthropometry, body composition, levels of vitamin D, blood glucose (including oral glucose tolerance test) and dietary assessments will be assessed periodically (every 3 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. Diet and exercise will be recommended as per the regular norms for overweight and obese subjects. Clinical and dietary profile, sunlight exposure, glycemic and lipid profile other metabolic parameters, body composition, hand grip strength, leukocyte telomerase length and telomerase activity will be assessed at enrolment time and one year intervention. As mentioned above, genes related to ageing will be evaluated. Appropriate statistical methods will be used to see effects of intervention with Vitamin D on metabolic state (particularly insulin resistance and glycemia) and leukocyte telomerase length and telomerase activity. Effects of polymorphisms of pro-ageing genes will be assessed
- Conditions
- Vitamin D Supplementation, PreDiabetes, Aging
- Being tested
- Randomized control trial of vitamin D supplementation
- Keywords
- Pre-diabetes, Type 2 Diabetes, Genes, Supplementation
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized control trial of vitamin D supplementationDietary supplement
This open-label randomized placebo-controlled prospective trial will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. Anthropometry, body composition, levels of vitamin D, blood glucose (including oral glucose tolerance test) and dietary assessments will be assessed periodically (every 3 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. Diet and exercise will be recommended as per the regular norms for overweight and obese subjects. Clinical and dietary profile, sunlight exposure, glycemic and lipid profile other metabolic parameters, body composition, hand grip strength, leukocyte telomerase length and telomerase activity will be assessed at enrolment time and one-year intervention. As mentioned above, genes related to ageing will be evaluated. Effects on polymorphisms of pro-ageing genes will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D and Placebo | Experimental | Doses of cholecalciferol (commercial name, Calcirol) 60,000IU (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. Receives: Dietary Supplement: Randomized control trial of vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of gene polymorphism and other markers in 500 subjects
single nucleotide polymorphisms [ACTN3, VDR, FOXO3A, SIRT1 and MSTN] Asian Indians with prediabetes.
Measured: 1 year
Secondary outcomes (1)
Effect of vitamin d supplementation on raging and other metabolic measures.
Vitamin D supplementation could Improve insulin action and glucose physiology, leading to lowering of blood glucose levels in persons with prediabetes.
- Increase/preserve leucocyte telomerase length and activity, thus having positive effects on ageing.
- Improve insulin action and glucose physiology, leading to lowering of blood glucose levels in persons with prediabetes.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Mar 2020
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D SupplementationStudies 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
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT04025489
- Sponsor's protocol ID
- DFI
- Status last verified
- Jul 2022
- First submitted
- 15 May 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Randomized Control Trial of Vitamin D Supplementation on Surrogate Markers of Ageing, Association/Interactions With Selected Ageing-related Genes, Glycemic and Metabolic Markers in North Indian Individuals With the Prediabetes
- ClinicalTrials.gov ID
- NCT04025489
- Acronym / sponsor ID
- DFI
- Conditions
- Vitamin D Supplementation, PreDiabetes, Aging
- Keywords
- Pre-diabetes, Type 2 Diabetes, Genes, Supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 19 Jul 2019 (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.
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 apparent accelerated aging 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 ageing-related genes, or interaction between the two. This study is based on the assumption that the supplementation of vitamin d could lead to reversal to normal glucose regulation and may slow aging process in individuals with pre-diabetes.
Detailed description
Asian Indians develop metabolic syndrome and diabetes earlier than in most population. In other words, Asian Indians have all the risk factors which may predispose to accelerated ageing; insulin resistance, dysglycemia, subclinical inflammation, and vasculopathy.
Vitamin D deficiency is widespread in both urban and rural populations of India. It is possible that vitamin D may also act on pathway related to aging which also are common to chronic diseases like diabetes. In this respect the surrogate markers of ageing (leukocyte telomerase length and telomerase activity) could be affected if vitamin D deficiency occurs. While some studies have shown relationship between vitamin D supplementation and leukocyte telomerase length in other populations, such study has not been systematically performed in Asian Indians. In this context, it is also not clear if some proposed genes of ageing may have some influence of development of prediabetes or diabetes and may interact with vitamin D. One of the candidate gene MSTN, according to our previous study, showed close correlation with excess body fat and decrease muscle mass, body composition characteristics conducive to development of diabetes. Additionally, deficiency of vitamin D could be linked to insulin resistance, prediabetes, though these issues have been debated. Some studies suggest that vitamin D supplementation may improve insulin sensitivity in Asian Indians. A research focusing on relationship of vitamin D supplementation with pro-ageing metabolic factors (glycemia, insulin resistance etc,), ageing related genes and surrogate markers of ageing is needed.
This study has two components; cross-sectional and prospective. Cross-sectional study will be of 2 years duration where 500 subjects from urban area of Delhi will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure. The population will be representative of different socio-economic strata of the society. In this, vitamin D levels, leukocyte telomerase length and telomerase activity in peripheral blood leukocytes, telomerase activity and single nucleotide polymorphisms [ACTN3, VDR, FOXO3A, SIRT1 and MSTN] in prediabetes Asian Indians.
Second part consists of open-label randomized placebo-controlled prospective trial, in which the investigators would be enrolling 200 prediabetic subjects with vitamin D deficiency. These subjects will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. Anthropometry, body composition, levels of vitamin D, blood glucose (including oral glucose tolerance test) and dietary assessments will be assessed periodically (every 3 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. Diet and exercise will be recommended as per the regular norms for overweight and obese subjects. Clinical and dietary profile, sunlight exposure, glycemic and lipid profile other metabolic parameters, body composition, hand grip strength, leukocyte telomerase length and telomerase activity will be assessed at enrolment time and one year intervention. As mentioned above, genes related to ageing will be evaluated. Appropriate statistical methods will be used to see effects of intervention with Vitamin D on metabolic state (particularly insulin resistance and glycemia) and leukocyte telomerase length and telomerase activity. Effects of polymorphisms of pro-ageing genes will be assessed
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D and Placebo | Experimental | Dietary Supplement: Randomized control trial of vitamin D supplementationDoses of cholecalciferol (commercial name, Calcirol) 60,000IU (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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pre-diabetes:
- Baseline blood level of 25 hydroxy vitamin D <30ng/dl.
- Aged 20-60 years
Key exclusion criteria (12 listed)
- Received Vitamin D or calcium supplementation in the previous six months.
- On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism and on any medication that activate steroid and xenobiotic receptors, and drugs used in transplantation.
- Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
- Known case of diabetes mellitus, HIV infection and other endocrine disorders.
- Design: Randomized open labeled placebo-controlled trial.
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 |
|---|---|---|
| Randomized control trial of vitamin D supplementationThis open-label randomized placebo-controlled prospective trial will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. Anthropometry, body composition, levels of vitamin D, blood glucose (including oral glucose tolerance test) and dietary assessments will be assessed periodically (every 3 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. Diet and exercise will be recommended as per the regular norms for overweight and obese subjects. Clinical and dietary profile, sunlight exposure, glycemic and lipid profile other metabolic parameters, body composition, hand grip strength, leukocyte telomerase length and telomerase activity will be assessed at enrolment time and one-year intervention. As mentioned above, genes related to ageing will be evaluated. Effects on polymorphisms of pro-ageing genes will be assessed. | Dietary supplement | Vitamin D and Placebo |
Primary outcome
Investigation of gene polymorphism and other markers in 500 subjects
Time frame: 1 year
single nucleotide polymorphisms [ACTN3, VDR, FOXO3A, SIRT1 and MSTN] Asian Indians with prediabetes.
1 secondary outcome
Effect of vitamin d supplementation on raging and other metabolic measures.
Time frame: 2 year
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Vitamin D Supplementation and PreDiabetes, run by Diabetes Foundation, India at 1 site in 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 5 inclusion and 12 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.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Investigation of gene polymorphism and other markers in 500 subjects (time frame: 1 year). 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.