An interventional study of vitamin D and placebo in Pre-diabetes, sponsored by Charles Drew University of Medicine and Science. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-06-14.
Sponsored by Charles Drew University of Medicine and Science · Not applicable, Interventional, and Prevention
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
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.
792 studies on the registry are indexed under Glucose Intolerance; 126 are open to participants now.
This study's enrollment of 117 is above the median of 60 across 656 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Charles Drew University of Medicine and Science is the lead sponsor of 43 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects with low vitamin D levels and pre-diabetes
Drug: placebo
Subjects with low vitamin D levels and pre-diabetes
Drug: vitamin D
liquid vitamin D3 dissolved in medium chain triglyceride once a week
medium chain triglyceride given once per week
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
Time frame: one year
Disposition Index
Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better
Time frame: Baseline, 3, 6, 9, 12 months
| Milestone | Placebo | Vitamin D |
|---|---|---|
| Started | 56 | 61 |
| Completed | 53 | 56 |
| Not completed | 3 | 5 |
| Withdrew: Lost to follow-up | 2 | 5 |
| Withdrew: Hypokalemia-affects insulin secretion | 1 | 0 |
Diabetes defined by a FPG\>=126 mg/dl or a 2-hr glucose concentration on an OGTT of \>=200 mg/dl
| percentage of participants | Placebo | Vitamin D |
|---|---|---|
| Percent of Subjects Who Develop Diabetes | 9 | 12 |
Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better
| Unitless | Placebo | Vitamin D |
|---|---|---|
| Dispostion Index at baseline | 1.4 ± 0.5 | 1.3 ± 0.4 |
| Disposition Index at 3 months | 1.5 ± 0.8 | 1.3 ± 0.5 |
| Disposition Index at 6 months | 1.4 ± 0.6 | 1.2 ± 0.5 |
| Disposition Index at 9 months | 1.3 ± 0.6 | 1.3 ± 0.4 |
| Disposition Index at 12 months | 1.6 ± 1.6 | 1.3 ± 0.5 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/53 (0%) | 0/53 (0%) |
| Vitamin D | — | 0/56 (0%) | 0/56 (0%) |
| Age, Categorical(Participants) | Placebo | Vitamin D | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 52 | 55 | 107 |
| >=65 years | 4 | 6 | 10 |
| Age Continuous(Years) | Placebo | Vitamin D | Total |
|---|---|---|---|
| Mean | 52.5 ± 7.0 | 52.3 ± 8.0 | 52.4 ± 7.5 |
| Sex: Female, Male(Participants) | Placebo | Vitamin D | Total |
|---|---|---|---|
| Female | 36 | 43 | 79 |
| Male | 20 | 18 | 38 |
| Region of Enrollment(participants) | Placebo | Vitamin D | Total |
|---|---|---|---|
| United States | 56 | 61 | 117 |
The record gives a start of Mar 2009, a primary completion of Jan 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2013, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Vitamin D
Charles Drew University of Medicine and Science