PrediabetesNCT01425424
Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study
A study testing Vitamin D supplementation in people with Prediabetes and Prehypertension, run by Pennington Biomedical Research Center at 7 sites in United States.
Trial summary
This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension) or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Prehypertension
- What is being tested?
- Vitamin D supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2012to Dec 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Male or Female 18 years or older presenting to The America Family Practice, Physicians Care Center offices or Egan Wellness Clinic/Anti-Aging \& Skin Care Spa.
- Agreeable to treatment with placebo or vitamin D 1000IU twice a day with food.
Who cannot join
- Women who are pregnant or nursing
- Anyone with chronic medical conditions requiring regular intake of any prescription medications.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Physicians Care Center
Baton Rouge, Louisiana, 70806
Bradley L. Meek, MD, Internal Medicine at Hennessy
Baton Rouge, Louisiana, 70808
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Metabolic Clinic Women's Hospital
Baton Rouge, Louisiana, 70809
Egan Wellness Clinic/AntiAging & Skin Care Spa
Covington, Louisiana, 70433
Amarica Family Practice Office (Second Location)
Durham, North Carolina, 27704
Amarica Family Practice Office (First Location)
Roxboro, North Carolina, 27573
About this study
This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension) or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D. This may reduce the chances of developing diabetes or high blood pressure or both later in life.
Read the detailed description
Study visits will measure temperature, fasting glucose, resting blood pressure, respiratory rate, height, weight and waist circumference. A brief medical History will be taken, followed by an abbreviated physical exam. A blood test to check your vitamin D level and routine chemistry including a complete lipid profile, liver and kidney function will be completed.
Based on your fasting glucose and/or resting blood pressure you will be in one of the three arms: prediabetes (arm 1), prehypertension (arm 2) or co-existing prediabetes and prehypertension (arm 3). After determining the arm of the study you are in, you will be randomly assigned to receive either a placebo or vitamin D supplementation.
If you are in the first arm with prediabetes (fasting glucose 100-125 mg/dL), the primary outcome measure will change in fasting glucose at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. If you are in the second arm with prehypertension (resting blood pressure 120-139/80-89 mm Hg), the primary outcome measure will change in resting blood pressure at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. If you are in third arm with prediabetes and prehypertension, both these measures will be taken at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. A repeat blood test to check vitamin D levels will be done at 8 and 16 weeks (and periodically as necessary) during the study.
Other measures will be taken as are routine in your doctor's office.
- Conditions
- Prediabetes, Prehypertension
- Being tested
- Vitamin D supplementation
- Keywords
- Vitamin D, Prediabetes, Prehypertension
- Medical subject headings
- Prediabetic State, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementationOther
Also called Vitamin D
Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Fasting glucose (blood sugar) | Experimental | This group is associated with a diagnosis of prediabetes Receives: Other: Vitamin D supplementation |
| Resting Blood pressure | Experimental | This group is associated with a diagnosis of prehypertension. Receives: Other: Vitamin D supplementation |
| Fasting Glucose & Resting Blood Pressure | Experimental | coexisting prediabetes and prehypertension Receives: Other: Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediabetes, Prehypertension and Vitamin D supplementation- A practice based clinical intervention
An analysis of the fasting glucose, resting blood pressure and/or both will be performed. A blood test to check your vitamin D level and routine chemistry including a complete lipid profile, liver and kidney function will also be done. At the end of 8 weeks fasting blood glucose and resting blood pressure will be measured. If the desired results (fasting glucose less than 100 mg/dL and/or resting blood pressure less than 120/80 mm Hg) are not seen these measures will be repeated at 16 weeks. You will be asked to stay in the study for up to 5 years.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: The PI was leaving Pennington
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Alok Gupta, MD, AAFP, FASH, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425424
- Sponsor's protocol ID
- PBRC 10036
- Status last verified
- Dec 2015
- First submitted
- 10 Aug 2011
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study
- ClinicalTrials.gov ID
- NCT01425424
- Acronym / sponsor ID
- PBRC 10036
- Conditions
- Prediabetes, Prehypertension
- Keywords
- Vitamin D, Prediabetes, Prehypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI was leaving Pennington
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Aug 2011 (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.
This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension) or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D. This may reduce the chances of developing diabetes or high blood pressure or both later in life.
Detailed description
Study visits will measure temperature, fasting glucose, resting blood pressure, respiratory rate, height, weight and waist circumference. A brief medical History will be taken, followed by an abbreviated physical exam. A blood test to check your vitamin D level and routine chemistry including a complete lipid profile, liver and kidney function will be completed.
Based on your fasting glucose and/or resting blood pressure you will be in one of the three arms: prediabetes (arm 1), prehypertension (arm 2) or co-existing prediabetes and prehypertension (arm 3). After determining the arm of the study you are in, you will be randomly assigned to receive either a placebo or vitamin D supplementation.
If you are in the first arm with prediabetes (fasting glucose 100-125 mg/dL), the primary outcome measure will change in fasting glucose at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. If you are in the second arm with prehypertension (resting blood pressure 120-139/80-89 mm Hg), the primary outcome measure will change in resting blood pressure at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. If you are in third arm with prediabetes and prehypertension, both these measures will be taken at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. A repeat blood test to check vitamin D levels will be done at 8 and 16 weeks (and periodically as necessary) during the study.
Other measures will be taken as are routine in your doctor's office.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasting glucose (blood sugar) | Experimental | Other: Vitamin D supplementationThis group is associated with a diagnosis of prediabetes |
| Resting Blood pressure | Experimental | Other: Vitamin D supplementationThis group is associated with a diagnosis of prehypertension. |
| Fasting Glucose & Resting Blood Pressure | Experimental | Other: Vitamin D supplementationcoexisting prediabetes and prehypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Male or Female 18 years or older presenting to The America Family Practice, Physicians Care Center offices or Egan Wellness Clinic/Anti-Aging \& Skin Care Spa.
- Agreeable to treatment with placebo or vitamin D 1000IU twice a day with food.
Key exclusion criteria (2 listed)
- Women who are pregnant or nursing
- Anyone with chronic medical conditions requiring regular intake of any prescription medications.
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 supplementationAlso: Vitamin DVitamin D | Other | Fasting Glucose & Resting Blood Pressure, Fasting glucose (blood sugar), Resting Blood pressure |
Primary outcome
Prediabetes, Prehypertension and Vitamin D supplementation- A practice based clinical intervention
Time frame: 8 weeks
An analysis of the fasting glucose, resting blood pressure and/or both will be performed. A blood test to check your vitamin D level and routine chemistry including a complete lipid profile, liver and kidney function will also be done. At the end of 8 weeks fasting blood glucose and resting blood pressure will be measured. If the desired results (fasting glucose less than 100 mg/dL and/or resting blood pressure less than 120/80 mm Hg) are not seen these measures will be repeated at 16 weeks. You will be asked to stay in the study for up to 5 years.
Results and safety
The study was stopped early (reason given: The PI was leaving Pennington). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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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.
Alok Gupta, MD, AAFP, FASH principal investigator
Pennington Biomedical Research Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplementation in people with Prediabetes and Prehypertension, run by Pennington Biomedical Research Center at 7 sites in United States.
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 2 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: stopped early, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
The study was stopped early (reason given: The PI was leaving Pennington). Results are not available in the source record.
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?
Prediabetes, Prehypertension and Vitamin D supplementation- A practice based clinical intervention (time frame: 8 weeks). 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 18 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.