PrediabetesNCT00749918
Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism
A study testing Cholecalciferol (vitamin D3) in people with Prediabetes and Vitamin D Deficiency, run by University of Minnesota at 1 site in United States.
Trial summary
This study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol (vitamin D3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2008
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Impaired fasting glucose
- Adult, age between 18 and 65
- Serum vitamin D level below 30 ng/mL
Who cannot join
- History of nephrolithiasis
- Any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin)
- Pregnancy
- Liver disease
- Renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Division of Endocrinology
Minneapolis, Minnesota, 55455
About this study
Official title: Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals
This study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.
Read the detailed description
A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0, baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH, and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod Millennium software.
- Conditions
- Prediabetes, Vitamin D Deficiency
- Being tested
- Cholecalciferol (vitamin D3)
- Keywords
- vitamin D, Cholecalciferol, Insulin sensitivity, MinMod Millennium, FSIGT, modified frequently sampled IV glucose tolerance test
- Medical subject headings
- Prediabetic State, Vitamin D Deficiency, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (vitamin D3)Dietary supplement
Also called Cholecalciferol by BIO-TECH Pharmacal, Inc.
Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Each subject was evaluated and data was collected before and after the intervention Receives: Dietary Supplement: Cholecalciferol (vitamin D3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.
Measured: At baseline and after 4 weeks of vitamin D supplementation
Secondary outcomes (2)
Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.
Measured: One month
Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionJun 2008
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.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Hennepin Healthcare Research Institute
- Investigators
- Cary Mariash, MD, Study director, University of MinnesotaShaban Nazarian, MD, Principal investigator, University of MinnesotaSidney Jones, MD, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749918
- Sponsor's protocol ID
- 0609M92006
- Status last verified
- Oct 2008
- First submitted
- 8 Sep 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals
- ClinicalTrials.gov ID
- NCT00749918
- Acronym / sponsor ID
- 0609M92006
- Conditions
- Prediabetes, Vitamin D Deficiency
- Keywords
- vitamin D, Cholecalciferol, Insulin sensitivity, MinMod Millennium, FSIGT, modified frequently sampled IV glucose tolerance test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Hennepin Healthcare Research Institute
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Sep 2008 (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 study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.
Detailed description
A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0, baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH, and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod Millennium software.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Cholecalciferol (vitamin D3)Each subject was evaluated and data was collected before and after the intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Impaired fasting glucose
- Adult, age between 18 and 65
- Serum vitamin D level below 30 ng/mL
Key exclusion criteria (5 listed)
- History of nephrolithiasis
- Any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin)
- Pregnancy
- Liver disease
- Renal disease
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 |
|---|---|---|
| Cholecalciferol (vitamin D3)Also: Cholecalciferol by BIO-TECH Pharmacal, Inc.Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month. | Dietary supplement | 1 |
Primary outcome
Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.
Time frame: At baseline and after 4 weeks of vitamin D supplementation
2 secondary outcomes
Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.
Time frame: One month
Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.
Time frame: One month
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 20 Oct 2008.
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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.
Cary Mariash, MD study director
University of Minnesota
Shaban Nazarian, MD principal investigator
University of Minnesota
Sidney Jones, MD study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol (vitamin D3) in people with Prediabetes and Vitamin D Deficiency, run by University of Minnesota at 1 site 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 3 inclusion and 5 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 20 Oct 2008. 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 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 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?
Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month. (time frame: At baseline and after 4 weeks of vitamin D supplementation). 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 20 Oct 2008.