Pre-diabetesNCT00876928
Vitamin D in Minorities With Prediabetes
A study testing vitamin D in people with Pre-diabetes, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 40.
- Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
- Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
- Serum 25-OHD less than 30 ng/ml
- Able and willing to provide informed consent
Who cannot join
- FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
- Major psychiatric disorder on medication (excluding successfully treated depression)
- Diagnosed diabetes mellitus
- HIV/AIDS
- Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
- History of carcinoma, except skin basal cell or squamous cell skin carcinomas
Show all 15Show fewer
- Heart failure, unstable angina or history of a myocardial infarction
- Alcohol or substance abuse
- Current treatment with glucocorticoids
- Current treatment with diabetes medications, including metformin
- Cushing's syndrome
- Primary hyperparathyroidism
- Nephrolithiasis
- Pregnancy or breast-feeding
- Regular visits to a tanning salon (unlikely in this minority population)
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University
Los Angeles, California, 90059
About this study
Official title: Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
Read the detailed description
Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.
- Conditions
- Pre-diabetes
- Being tested
- vitamin D, placebo
- Keywords
- pre-diabetes, minorities, oral glucose tolerance test, disposition index, insulin secretion, insulin sensitivity, diabetes
- Medical subject headings
- Glucose Intolerance, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDrug
liquid vitamin D3 dissolved in medium chain triglyceride once a week
placeboDrug
medium chain triglyceride given once per week
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects with low vitamin D levels and pre-diabetes Receives: Drug: placebo |
| vitamin D | Experimental | Subjects with low vitamin D levels and pre-diabetes Receives: Drug: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects Who Develop Diabetes
Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl
Measured: one year
Secondary outcomes (1)
Disposition Index
Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better
Measured: Baseline, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Mayer Davidson, Charles Drew University of Medicine and Science
- Investigators
- Mayer B. Davidson, MD, Principal investigator, Charles Drew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876928
- Sponsor's protocol ID
- Vitamin D-Prediabetes
- Other IDs
- 1-09-CR-15
- Status last verified
- Apr 2013
- First submitted
- 6 Apr 2009
- Last updated
- 14 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sinha-Hikim I, Duran P, Shen R, Lee M, Friedman TC, Davidson MB. Effect of long term vitamin D supplementation on biomarkers of inflammation in Latino and African-American subjects with pre-diabetes and hypovitaminosis D. Horm Metab Res. 2015 Apr;47(4):280-3. doi: 10.1055/s-0034-1383652. Epub 2014 Jul 10.
PubMed 25011019Davidson MB, Duran P, Lee ML, Friedman TC. High-dose vitamin D supplementation in people with prediabetes and hypovitaminosis D. Diabetes Care. 2013 Feb;36(2):260-6. doi: 10.2337/dc12-1204. Epub 2012 Oct 1.
PubMed 23033239
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population
- ClinicalTrials.gov ID
- NCT00876928
- Acronym / sponsor ID
- Vitamin D-Prediabetes
- Conditions
- Pre-diabetes
- Keywords
- pre-diabetes, minorities, oral glucose tolerance test, disposition index, insulin secretion, insulin sensitivity, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Mar 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Posted 14 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
Detailed description
Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboSubjects with low vitamin D levels and pre-diabetes |
| vitamin D | Experimental | Drug: vitamin DSubjects with low vitamin D levels and pre-diabetes |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 40.
- Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
- Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
- Serum 25-OHD less than 30 ng/ml
- Able and willing to provide informed consent
Key exclusion criteria (15 listed)
- FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
- Major psychiatric disorder on medication (excluding successfully treated depression)
- Diagnosed diabetes mellitus
- HIV/AIDS
- Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
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 Dliquid vitamin D3 dissolved in medium chain triglyceride once a week | Drug | vitamin D |
| placebomedium chain triglyceride given once per week | Drug | Placebo |
Primary outcome
Percent of Subjects Who Develop Diabetes
Time frame: one year
Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl
1 secondary outcome
Disposition Index
Time frame: Baseline, 3, 6, 9, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25011019Sinha-Hikim I, Duran P, Shen R, Lee M, Friedman TC, Davidson MB. Effect of long term vitamin D supplementation on biomarkers of inflammation in Latino and African-American subjects with pre-diabetes and hypovitaminosis D. Horm Metab Res. 2015 Apr;47(4):280-3. doi: 10.1055/s-0034-1383652. Epub 2014 Jul 10.
- Derived from this study: PubMed 23033239Davidson MB, Duran P, Lee ML, Friedman TC. High-dose vitamin D supplementation in people with prediabetes and hypovitaminosis D. Diabetes Care. 2013 Feb;36(2):260-6. doi: 10.2337/dc12-1204. Epub 2012 Oct 1.
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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.
Mayer B. Davidson, MD principal investigator
Charles Drew University
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 in people with Pre-diabetes, run by Charles Drew University of Medicine and Science 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 5 inclusion and 15 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 14 Jun 2013. 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. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects Who Develop Diabetes (time frame: one year). 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 NCT00876928, which also lists 2 linked publications.
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 14 Jun 2013.