Vitamin D in Minorities With Prediabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin D and Type 2 Diabetes Study

NCT01942694

Prediabetes Type 2 Diabetes

COMPLETED NA

Effect of Vitamin D Supplementation on Glucose Tolerance in Subjects at Risk for Diabetes With Low Vitamin D.

NCT01726777

Type 2 Diabetes Mellitus Vitamin D Deficiency

COMPLETED PHASE2

Can Vitamin D Supplementation Prevent Type 2 Diabetes?

NCT02112721

Type 2 Diabetes Mellitus

COMPLETED PHASE4

Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism

NCT00749918

Prediabetes Vitamin D Deficiency

COMPLETED NA

Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance

NCT01779908

Vitamin D-deficient Insulin-resistant

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pre-diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Subjects with low vitamin D levels and pre-diabetes

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

medium chain triglyceride given once per week

vitamin D

Subjects with low vitamin D levels and pre-diabetes

Group Type EXPERIMENTAL

vitamin D

Intervention Type DRUG

liquid vitamin D3 dissolved in medium chain triglyceride once a week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vitamin D

liquid vitamin D3 dissolved in medium chain triglyceride once a week

Intervention Type DRUG

placebo

medium chain triglyceride given once per week

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age greater than 40.
2. Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
3. Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
4. Serum 25-OHD less than 30 ng/ml
5. Able and willing to provide informed consent

Exclusion Criteria

1. FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
2. Major psychiatric disorder on medication (excluding successfully treated depression)
3. Diagnosed diabetes mellitus
4. HIV/AIDS
5. Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
6. History of carcinoma, except skin basal cell or squamous cell skin carcinomas
7. Heart failure, unstable angina or history of a myocardial infarction
8. Alcohol or substance abuse
9. Current treatment with glucocorticoids
10. Current treatment with diabetes medications, including metformin
11. Cushing's syndrome
12. Primary hyperparathyroidism
13. Nephrolithiasis
14. Pregnancy or breast-feeding
15. Regular visits to a tanning salon (unlikely in this minority population)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No