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D Vitamin Intervention in VA (DIVA)

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ClinicalTrials.gov Identifier: NCT01375660
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : February 5, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Impaired Fasting Glucose
Impaired Glucose Tolerance
Vitamin D Insufficiency
Interventions Drug: Placebo
Drug: 50K vitamin D2
Enrollment 205

Recruitment Details Participants were recruited among African American Male veterans coming for medical care to Jesse Brown VA Medical Center in Chicago between May 2011 and December 2012.
Pre-assignment Details  
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description supplement of vitamin D 400 units provided to all subjects in addition to placebo. supplement of vitamin D 400 units provided to all subjects in addition to 50K vitamin D2.
Period Title: Overall Study
Started 102 103
Completed 86 87
Not Completed 16 16
Arm/Group Title Placebo 50K Vitamin D2 Total
Hide Arm/Group Description Supplement of vitamin D 400 units provided to all subjects in addition to placebo. Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K. Total of all reporting groups
Overall Number of Baseline Participants 86 87 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
35-85 Years Number Analyzed 86 participants 87 participants 173 participants
86 87 173
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 86 participants 87 participants 173 participants
86 87 173
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
African American Male Veterans Number Analyzed 86 participants 87 participants 173 participants
86 87 173
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 86 participants 87 participants 173 participants
86 87 173
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 86 participants 87 participants 173 participants
31.5  (2.4) 32.4  (2.9) 31.9  (2.65)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percentage of A1C
Number Analyzed 86 participants 87 participants 173 participants
6.1  (0.20) 6.1  (0.26) 6.1  (0.26)
Vit D  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 86 participants 87 participants 173 participants
14.0  (4.8) 14.7  (4.7) 14.3  (4.8)
1.Primary Outcome
Title Oral Glucose Insulin Sensitivity (OGIS)
Hide Description

Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test.

The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline.

Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description:
Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
Overall Number of Participants Analyzed 86 87
Mean (Standard Deviation)
Unit of Measure: ml/min/m^2 of body surface area
-16.0  (55.83) 7.8  (56.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50K Vitamin D2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in HbA1c From Baseline at 12 Months
Hide Description [Not Specified]
Time Frame Baseline and 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description:
Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
Overall Number of Participants Analyzed 86 87
Mean (Standard Deviation)
Unit of Measure: percentage of A1C
0.01  (0.21) -0.01  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50K Vitamin D2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Insulin Sensitivity by Matsuda Composite
Hide Description

Insulin Sensitivity by Matsuda Composite – index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The formula is different from a formula for OGIS.

Matsuda composite calculated based on formula 10^4/Square Root of [(fasting glucose x fasting insulin) x (mean glucose x mean insulin)] (Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic glucose clamp. Diabetes Care. 1999;22:1462-1470) Unit of measure is 10000/√[(µU/mL)/(mg/dL)]x[(µU/mL)/(mg/dL)].

Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description:
Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
Overall Number of Participants Analyzed 86 87
Mean (Standard Deviation)
Unit of Measure: 10^4/√[(µU/mL)/(mg/dL)x(µU/mL)/(mg/dL)]
0.13  (1.43) 0.44  (1.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50K Vitamin D2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Insulinogenic Index-30
Hide Description

Index of insulin secretion, higher index means higher insulin secretion. It is calculated by a special formula using insulin and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.

Insulin secretion was assessed based on formula Insulinogenic index-30 [(insulin at 30 min - fasting insulin)/(glucose at 30 min - fasting glucose)] (Kosaka K, Hagura R, Kuzuya T. Insulin responses in equivocal and definite diabetes, with special reference to subjects who had mild glucose intolerance but later developed definite diabetes. Diabetes. 1977;26:944-952)

Time Frame 12 Month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description:
Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
Overall Number of Participants Analyzed 86 87
Mean (Standard Deviation)
Unit of Measure: (µU/mL)/(mg/dL)
-0.03  (1.10) 0.26  (1.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50K Vitamin D2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments P Value for Insulinogenic Index-30 = 0.34
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title C-Peptidogenic Index-30
Hide Description

Index of insulin secretion, higher index means higher insulin secretion. C-peptide circulates in blood in amounts equal to insulin because insulin and C-peptide are linked when first made by the pancreas. C-peptide is more stable in blood than insulin; therefore it can be reliably used to evaluate insulin secretion. It is calculated by a special formula using C-peptide and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.

Insulin secretion was assessed based on formula C-Peptidogenic index-30 [(C-Peptide at 30 min – fasting C-peptide)/(glucose at 30 min – fasting glucose)]Bergstrom RW, Wahl PW, Leonetti DL, Fujimoto WY. Association of fasting glucose levels with a delayed secretion of insulin after oral glucose in subjects with glucose intolerance. J Clin Endocrinol Metab. 1990;71:1447-1453.)

Time Frame 12 Month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description:
Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
Overall Number of Participants Analyzed 86 87
Mean (Standard Deviation)
Unit of Measure: (ng/mL)/(mg/dL)
-0.64  (15.84) 5.32  (17.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50K Vitamin D2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Incident Diabetes
Hide Description [Not Specified]
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description:
Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
Overall Number of Participants Analyzed 86 87
Measure Type: Number
Unit of Measure: participants
9 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50K Vitamin D2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.869
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Post-Hoc Outcome
Title Change in Glycemia
Hide Description [Not Specified]
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description:
Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
Overall Number of Participants Analyzed 86 87
Measure Type: Number
Unit of Measure: percentage of participants
8.3 31.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 50K Vitamin D2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 12 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 50K Vitamin D2
Hide Arm/Group Description Supplement of vitamin D 400 units provided to all subjects in addition to placebo. Supplement of vitamin D 400 units provided to all subjects in addition get to D2 50K.
All-Cause Mortality
Placebo 50K Vitamin D2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 50K Vitamin D2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/87 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 50K Vitamin D2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/87 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Barengolts, Attending Endocrinologist, Chief, Section of Endocrinology
Organization: Jesse Brown VA Medical Center
Phone: 312-569-7651
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01375660     History of Changes
Other Study ID Numbers: CLIN-001-10S
First Submitted: June 15, 2011
First Posted: June 17, 2011
Results First Submitted: November 25, 2014
Results First Posted: February 5, 2015
Last Update Posted: March 6, 2015