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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

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo supplement of vitamin D 400 units provided to all subjects in addition to placebo.
50K Vitamin D2 supplement of vitamin D 400 units provided to all subjects in addition to 50K vitamin D2.

Participant Flow:   Overall Study
    Placebo   50K Vitamin D2
STARTED   102   103 
COMPLETED   86   87 
NOT COMPLETED   16   16 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
50K Vitamin D2 Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
Total Total of all reporting groups

Baseline Measures
   Placebo   50K Vitamin D2   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   87   173 
Age, Customized 
[Units: Participants]
     
35-85 Years   86   87   173 
Gender, Customized 
[Units: Participants]
     
Male   86   87   173 
Race/Ethnicity, Customized 
[Units: Participants]
     
African American Male Veterans   86   87   173 
Region of Enrollment 
[Units: Participants]
     
United States   86   87   173 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 31.5  (2.4)   32.4  (2.9)   31.9  (2.65) 
HbA1c 
[Units: Percentage of A1C]
Mean (Standard Deviation)
 6.1  (0.20)   6.1  (0.26)   6.1  (0.26) 
Vit D 
[Units: Ng/ml]
Mean (Standard Deviation)
 14.0  (4.8)   14.7  (4.7)   14.3  (4.8) 


  Outcome Measures

1.  Primary:   Oral Glucose Insulin Sensitivity (OGIS)   [ Time Frame: 12 months ]

2.  Secondary:   Change in HbA1c From Baseline at 12 Months   [ Time Frame: Baseline and 12 Months ]

3.  Secondary:   Insulin Sensitivity by Matsuda Composite   [ Time Frame: 12 Months ]

4.  Secondary:   Insulinogenic Index-30   [ Time Frame: 12 Month ]

5.  Secondary:   C-Peptidogenic Index-30   [ Time Frame: 12 Month ]

6.  Secondary:   Incident Diabetes   [ Time Frame: 12 Months ]

7.  Post-Hoc:   Change in Glycemia   [ Time Frame: 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Elena.Barengolts@va.gov


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
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