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Vitamin D in Minorities With Prediabetes

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ClinicalTrials.gov Identifier: NCT00876928
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : June 14, 2013
Last Update Posted : June 14, 2013
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Mayer Davidson, Charles Drew University of Medicine and Science

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Pre-diabetes
Interventions Drug: vitamin D
Drug: placebo
Enrollment 117
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description

Subjects with low vitamin D levels and pre-diabetes

Medium chain triglyceride given once per week

Subjects with low vitamin D levels and pre-diabetes

Liquid vitamin D3 dissolved in medium chain triglyceride once per week

Period Title: Overall Study
Started 56 61
Completed 53 56
Not Completed 3 5
Reason Not Completed
Lost to Follow-up             2             5
Hypokalemia-affects insulin secretion             1             0
Arm/Group Title Placebo Vitamin D Total
Hide Arm/Group Description Subjects with low vitamin D levels and pre-diabetes Subjects with low vitamin D levels and pre-diabetes Total of all reporting groups
Overall Number of Baseline Participants 56 61 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 61 participants 117 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
  92.9%
55
  90.2%
107
  91.5%
>=65 years
4
   7.1%
6
   9.8%
10
   8.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 61 participants 117 participants
52.5  (7.0) 52.3  (8.0) 52.4  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 61 participants 117 participants
Female
36
  64.3%
43
  70.5%
79
  67.5%
Male
20
  35.7%
18
  29.5%
38
  32.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 56 participants 61 participants 117 participants
56 61 117
1.Primary Outcome
Title Percent of Subjects Who Develop Diabetes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Minorities with pre-diabetes and hypovitaminosis D
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description:
Subjects with low vitamin D levels and pre-diabetes
Subjects with low vitamin D levels and pre-diabetes
Overall Number of Participants Analyzed 53 56
Measure Type: Number
Unit of Measure: percentage of participants
9 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D
Comments Null hypothesis is that there is no effect of vitamin D on the development of diabetes in people with pre-diabetes and hypovitaminosis D. There were no published data when this trial was started on the effect of vitamin D in pre-diabetes making a power calculation difficult.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments A chi square test was used for the number of participants developing diabetes and a 2-way repeated measures ANOVA for the disposition index
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent of patients developing diabetes
Estimated Value 10
Confidence Interval (2-Sided) 95%
8 to 12
Estimation Comments Primary outcome compared the number of participants developing diabetes after receiving vitamin D or placebo for one year. Secondary outcome compared changes in 2-way repeated measures ANOVA; therefore,no confidence intervals/dispersion parameters
2.Secondary Outcome
Title Disposition Index
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent to treat
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description:
Subjects with low vitamin D levels and pre-diabetes
Subjects with low vitamin D levels and pre-diabetes
Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: Unitless
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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vitamin D
Comments The null hypothesis is that there would be no difference in the changes in the Disposition Index between the 2 groups over the year.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vitamin D
Hide Arm/Group Description Subjects with low vitamin D levels and pre-diabetes Subjects with low vitamin D levels and pre-diabetes
All-Cause Mortality
Placebo Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/56 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/56 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mayer B. Davidson, MD
Organization: Charles R. Drew University
Phone: 323 357-3439
EMail: mayerdavidson@cdrewu.edu
Layout table for additonal information
Responsible Party: Mayer Davidson, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00876928    
Other Study ID Numbers: Vitamin D-Prediabetes
1-09-CR-15 ( Other Grant/Funding Number: American Diabetes Association )
First Submitted: April 6, 2009
First Posted: April 7, 2009
Results First Submitted: July 3, 2012
Results First Posted: June 14, 2013
Last Update Posted: June 14, 2013