PrediabetesPREVENT-WINNCT02513888
Prevention of Type 2 Diabetes With Vitamin D Supplementation
A study testing vitamin D + diet and lifestyle in people with Prediabetes, run by Diabetes Foundation, India at 1 site in India.
Trial summary
PREVENT-WIN study has three components. The work plan will have the following S\&T components. Component 1: Cross-sectional Study Cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- vitamin D + diet and lifestyle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2013to 31 Dec 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Prediabetes:
- Fasting blood glucose ≥100mg/dl and <126mg/dl, or
- 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 g anhydrous oral glucose), and 2. Baseline level of 25 hydroxy vitamin D <30ng/dl. 3. Women aged 20-60 years
Who cannot join
- 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 (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.)
- Pregnancy and lactation at the time of study.
- 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
Comprehensive Rural Health Services Project, AIIMS
Ballabgarh, Haryana, 121004
About this study
Official title: Prevention of Type 2 Diabetes in Women With Prediabetes Using Vitamin D Supplementation and Lifestyle Intervention in North India (PREVENT-WIN Study)
PREVENT-WIN study has three components.
The work plan will have the following S\&T components. Component 1: Cross-sectional Study
Read more
Cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure.
Component 2: Prospective Study
This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women with vitamin D deficiency. The women will be recruited from cross-sectional study, out patient department and health camps and they will be followed up for 2 years. The women will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be compared.
Component 3: Information Education and Communication (IEC) Activities:
There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas. IEC material will be developed and IEC activities through various modes like lectures, workshops, group discussions, leaflets/booklets distribution and audio video media shows (Hindi and English) will be used for educating health professionals, Medical and paramedical workers and various village level health functionaries like, Multi purpose workers, anganwadi workers, Accredited Social Health Activist under National Rural Health Mission of Government of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told about the benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun exposure and adverse health effects of vitamin D deficiency.
- Conditions
- Prediabetes
- Being tested
- vitamin D + diet and lifestyle, Placebo + diet and lifestyle
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D + diet and lifestyleDietary supplement
subjects will be given vitamin D along with diet and lifestyle modification counselling
Placebo + diet and lifestyleDietary supplement
placebo along with diet and lifestyle modification counselling
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D + diet and lifestyle | Experimental | subjects will be given vitamin D supplement will be given along with diet nd lifestyle modification Receives: Dietary Supplement: vitamin D + diet and lifestyle |
| placebo + diet and lifestyle | Placebo comparator | Subjects will be given placebo with diet and lifestyle Receives: Dietary Supplement: Placebo + diet and lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting glucose (mg/dL)
Measured: 2 years
Secondary outcomes (1)
TC (mg/dL)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study start1 Feb 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, India
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Puneet Misra, MD, Principal investigator, All India Institute of Medical Sciences, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513888
- Sponsor's protocol ID
- PREVENT_WIN_RURAL
- Acronym
- PREVENT-WIN
- Status last verified
- Jul 2018
- First submitted
- 29 Jul 2015
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Misra P, Kant S, Misra A, Jha S, Kardam P, Thakur N, Bhatt SP. A Community Based Randomized Controlled Trial to See the Effect of Vitamin D Supplementation on Development of Diabetes Among Women with Prediabetes Residing in A Rural Community of Northern India. J Family Med Prim Care. 2021 Aug;10(8):3122-3129. doi: 10.4103/jfmpc.jfmpc_311_21. Epub 2021 Aug 27.
PubMed 34660457
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Type 2 Diabetes in Women With Prediabetes Using Vitamin D Supplementation and Lifestyle Intervention in North India (PREVENT-WIN Study)
- ClinicalTrials.gov ID
- NCT02513888
- Acronym / sponsor ID
- PREVENT-WIN / PREVENT_WIN_RURAL
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, India
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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.
PREVENT-WIN study has three components.
The work plan will have the following S\&T components. Component 1: Cross-sectional Study
Cross-sectional study will be of 1.5 years where 400 women from rural will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure.
Component 2: Prospective Study
This open-label randomized placebo-controlled trial would be done in 150 pre-diabetic women with vitamin D deficiency. The women will be recruited from cross-sectional study, out patient department and health camps and they will be followed up for 2 years. The women will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. The levels of vitamin D and blood glucose will be assessed periodically (every 6 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. At the end of the study, incidence of T2DM in both groups will be compared.
Component 3: Information Education and Communication (IEC) Activities:
There is a paucity of IEC material on vitamin D deficiency in women residing in rural areas. IEC material will be developed and IEC activities through various modes like lectures, workshops, group discussions, leaflets/booklets distribution and audio video media shows (Hindi and English) will be used for educating health professionals, Medical and paramedical workers and various village level health functionaries like, Multi purpose workers, anganwadi workers, Accredited Social Health Activist under National Rural Health Mission of Government of India (ASHA). Besides this, Self Help Groups (SHGs) and women will be told about the benefits of balance diet, dietary intake of calcium, vitamin D, benefits of sun exposure and adverse health effects of vitamin D deficiency.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D + diet and lifestyle | Experimental | Dietary Supplement: vitamin D + diet and lifestylesubjects will be given vitamin D supplement will be given along with diet nd lifestyle modification |
| placebo + diet and lifestyle | Placebo comparator | Dietary Supplement: Placebo + diet and lifestyleSubjects will be given placebo with diet and lifestyle |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Prediabetes:
Key exclusion criteria (7 listed)
- 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 (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.)
- Pregnancy and lactation at the time of study.
- Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc.
- Known case of HIV infection.
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 + diet and lifestylesubjects will be given vitamin D along with diet and lifestyle modification counselling | Dietary supplement | Vitamin D + diet and lifestyle |
| Placebo + diet and lifestyleplacebo along with diet and lifestyle modification counselling | Dietary supplement | placebo + diet and lifestyle |
Primary outcome
fasting glucose (mg/dL)
Time frame: 2 years
1 secondary outcome
TC (mg/dL)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 34660457Misra P, Kant S, Misra A, Jha S, Kardam P, Thakur N, Bhatt SP. A Community Based Randomized Controlled Trial to See the Effect of Vitamin D Supplementation on Development of Diabetes Among Women with Prediabetes Residing in A Rural Community of Northern India. J Family Med Prim Care. 2021 Aug;10(8):3122-3129. doi: 10.4103/jfmpc.jfmpc_311_21. Epub 2021 Aug 27.
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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.
Puneet Misra, MD principal investigator
All India Institute of Medical Sciences, New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D + diet and lifestyle in people with 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 27 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting glucose (mg/dL) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02513888, which also lists 1 linked publication.
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 27 Jun 2023.