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Trial record 1 of 1 for:    NCT01942694
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Vitamin D and Type 2 Diabetes Study (D2d)

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ClinicalTrials.gov Identifier: NCT01942694
Recruitment Status : Active, not recruiting
First Posted : September 16, 2013
Results First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Dietary Supplements (ODS)
American Diabetes Association
Information provided by (Responsible Party):
Tufts Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Prediabetes
Type 2 Diabetes
Interventions Dietary Supplement: Vitamin D (Cholecalciferol)
Other: Placebo
Enrollment 2423
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Period Title: Overall Study
Started 1212 1211
Completed 1211 1211
Not Completed 1 0
Arm/Group Title Placebo Vitamin D (Cholecalciferol) Total
Hide Arm/Group Description

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Total of all reporting groups
Overall Number of Baseline Participants 1212 1211 2423
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1212 participants 1211 participants 2423 participants
60.4  (10.0) 59.6  (9.9) 60.0  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1212 participants 1211 participants 2423 participants
Female
545
  45.0%
541
  44.7%
1086
  44.8%
Male
667
  55.0%
670
  55.3%
1337
  55.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1212 participants 1211 participants 2423 participants
Hispanic or Latino
105
   8.7%
120
   9.9%
225
   9.3%
Not Hispanic or Latino
1107
  91.3%
1091
  90.1%
2198
  90.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1212 participants 1211 participants 2423 participants
American Indian or Alaska Native
8
   0.7%
5
   0.4%
13
   0.5%
Asian
64
   5.3%
66
   5.5%
130
   5.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
5
   0.4%
5
   0.2%
Black or African American
315
  26.0%
301
  24.9%
616
  25.4%
White
806
  66.5%
810
  66.9%
1616
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
19
   1.6%
24
   2.0%
43
   1.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1212 participants 1211 participants 2423 participants
1212 1211 2423
Fasting plasma glucose (mg/dl)  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 1212 participants 1211 participants 2423 participants
107.8  (7.4) 108.0  (7.4) 107.9  (7.4)
2-Hr post-load plasma glucose (mg/dl)  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 1212 participants 1211 participants 2423 participants
137.6  (34.3) 136.9  (34.3) 137.2  (34.3)
Glycated hemoglobin (%)  
Median (Standard Deviation)
Unit of measure:  %
Number Analyzed 1212 participants 1211 participants 2423 participants
5.9  (0.2) 5.9  (0.2) 5.9  (0.2)
Serum 25-hydroxyvitamin D (ng/ml)  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 1212 participants 1211 participants 2423 participants
28.2  (10.1) 27.7  (10.2) 28.0  (10.2)
1.Primary Outcome
Title Time to Development of Diabetes
Hide Description New-onset diabetes was based on annual glycemic testing of fasting plasma glucose, glycated hemoglobin, and 2-hour post-load plasma glucose and semiannual testing of fasting plasma glucose and glycated hemoglobin. If two or three of the glycemic measures met the 2010 ADA thresholds for diabetes, the participant was considered to have met the diabetes outcome. When only the measure for fasting plasma glucose or glycated hemoglobin met the threshold, confirmatory testing was performed for the positive measure within 8 weeks. If only the measure for 2-hour post-load plasma glucose met the threshold, then a 75-g oral glucose tolerance test to reassess all three glycemic measures was repeated. If the repeat measure was positive or both fasting plasma glucose and glycated hemoglobin were positive (in the case of a repeat oral glucose tolerance test), than the participant was considered to have met the diabetes outcome.
Time Frame Approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description:

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Overall Number of Participants Analyzed 1212 1211
Measure Type: Count of Participants
Unit of Measure: Participants
323 293
2.Secondary Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD Concentration
Hide Description [Not Specified]
Time Frame Approximately 48 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation)
Hide Description Race and ethnic group were reporting by the participant. The category "other" includes American Indian or Alaska Native; Native Hawaiian or other Pacific Islander; and other race. Ethnic group includes any race.
Time Frame Approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description:

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Overall Number of Participants Analyzed 1212 1211
Measure Type: Count of Participants
Unit of Measure: Participants
Race: White 806 810
Race: Black 315 301
Race: Other 91 100
Ethnic Group: Hispanic 105 120
Ethnic Group: Non-Hispanic 1107 1091
4.Secondary Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria)
Hide Description Participants met at least two of three glycemic criteria for prediabetes: fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mmol per liter); plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mmol per liter) (impaired glucose tolerance); and glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mmol per mole).
Time Frame Approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description:

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Overall Number of Participants Analyzed 1212 1211
Measure Type: Count of Participants
Unit of Measure: Participants
Met all three criteria 429 427
Met two criteria 783 784
5.Secondary Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI
Hide Description [Not Specified]
Time Frame Approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description:

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Overall Number of Participants Analyzed 1212 1211
Measure Type: Count of Participants
Unit of Measure: Participants
<30 429 435
≥30 783 776
6.Secondary Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference
Hide Description [Not Specified]
Time Frame Approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description:

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Overall Number of Participants Analyzed 1212 1211
Measure Type: Count of Participants
Unit of Measure: Participants
<Median of 104.2 cm 585 620
≥Median of 104.2 cm 627 591
7.Secondary Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age
Hide Description [Not Specified]
Time Frame Approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description:

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Overall Number of Participants Analyzed 1212 1211
Measure Type: Count of Participants
Unit of Measure: Participants
25-44
103
   8.5%
106
   8.8%
45-59
439
  36.2%
468
  38.6%
≥ 60
670
  55.3%
637
  52.6%
8.Secondary Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure)
Hide Description [Not Specified]
Time Frame Approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description:

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Overall Number of Participants Analyzed 1212 1211
Measure Type: Count of Participants
Unit of Measure: Participants
At or above 37° north latitude 898 892
Below 37° north latitude 314 319
9.Secondary Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From Supplements
Hide Description [Not Specified]
Time Frame Approximately 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description:

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Overall Number of Participants Analyzed 1212 1211
Measure Type: Count of Participants
Unit of Measure: Participants
No intake 793 826
Any intake 419 385
10.Secondary Outcome
Title Blood Plasma 25OHD Concentration.
Hide Description [Not Specified]
Time Frame Approximately 48 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Number of Participants With Adverse Events.
Hide Description [Not Specified]
Time Frame Approximately 48 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Change in Blood Pressure as a Continuous Variable.
Hide Description [Not Specified]
Time Frame Approximately 48 months
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Number of Participants Who Discontinue Study Pills.
Hide Description [Not Specified]
Time Frame Approximately 48 months
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Change in FPG as a Continuous Variable.
Hide Description [Not Specified]
Time Frame Every 12 months for approximately 48 months
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Change in 2hPG as a Continuous Variable.
Hide Description [Not Specified]
Time Frame Every 12 months for approximately 48 months.
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Change in HbA1c as a Continuous Variable.
Hide Description [Not Specified]
Time Frame Every 6 months for approximately 48 months
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Measurement of Insulin Resistance (Derived From the OGTT).
Hide Description [Not Specified]
Time Frame Every 12 months for approximately 48 months
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Measurement of Beta Cell Secretion (Derived From the OGTT)
Hide Description [Not Specified]
Time Frame Every 12 months for approximately 48 months
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Identification of Characteristics Associated With the Variability in Achieved 25OHD Concentration.
Hide Description [Not Specified]
Time Frame Every 12 months for approximately 48 months
Outcome Measure Data Not Reported
20.Other Pre-specified Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Sex
Hide Description [Not Specified]
Time Frame Approximately 48 months.
Outcome Measure Data Not Reported
21.Other Pre-specified Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Ethnicity
Hide Description [Not Specified]
Time Frame Approximately 48 months.
Outcome Measure Data Not Reported
22.Other Pre-specified Outcome
Title Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 2 Hour Plasma Glucose
Hide Description [Not Specified]
Time Frame Approximately 48 months
Outcome Measure Data Not Reported
23.Other Pre-specified Outcome
Title Time to Development of Cancer.
Hide Description [Not Specified]
Time Frame Approximately 48 months.
Outcome Measure Data Not Reported
24.Other Pre-specified Outcome
Title Time to Development of Cardiovascular Event.
Hide Description [Not Specified]
Time Frame Approximately 48 months.
Outcome Measure Data Not Reported
25.Other Pre-specified Outcome
Title Incidence of Cancer in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria.
Hide Description [Not Specified]
Time Frame Approximately 48 months.
Outcome Measure Data Not Reported
26.Other Pre-specified Outcome
Title Incidence of Cardiovascular Disease in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria.
Hide Description [Not Specified]
Time Frame Approximately 48 months.
Outcome Measure Data Not Reported
27.Other Pre-specified Outcome
Title Quality of Life and Mood Scores in Pre-diabetes Population Using a Validated Instrument (PROMIS-29 Profile v2.0 and a General Question on Perception of Overall Health From the PROMIS Scale 1.2).
Hide Description [Not Specified]
Time Frame One time assessment at the month 24 visit.
Outcome Measure Data Not Reported
Time Frame 2.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vitamin D (Cholecalciferol)
Hide Arm/Group Description

One pill daily

Placebo: Administered as one soft-gel pill daily by mouth

One vitamin D pill daily

Vitamin D (Cholecalciferol): Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

All-Cause Mortality
Placebo Vitamin D (Cholecalciferol)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/1212 (0.41%)      5/1211 (0.41%)    
Hide Serious Adverse Events
Placebo Vitamin D (Cholecalciferol)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   153/1212 (12.62%)      173/1211 (14.29%)    
Cardiac disorders     
Death   5/1212 (0.41%)  5/1211 (0.41%) 
Hospitalization   148/1212 (12.21%)  168/1211 (13.87%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Vitamin D (Cholecalciferol)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/1212 (2.15%)      31/1211 (2.56%)    
Endocrine disorders     
Hypercalcemia   3/1212 (0.25%)  3 5/1211 (0.41%)  5
Fasting urine calcium: creatinine ratio >0.375   1/1212 (0.08%)  1 1/1211 (0.08%)  1
Low estimated glomerular filtration rate   2/1212 (0.17%)  2 1/1211 (0.08%)  1
Nephrolithiasis   20/1212 (1.65%)  21 24/1211 (1.98%)  25
Indicates events were collected by systematic assessment
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: Dr. Anastassios Pittas
Organization: Division of Endocrinology, Diabetes, and Metabolism, Tufts Medical Center
Phone: 617-636-3232
EMail: apittas@tuftsmedicalcenter.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01942694    
Obsolete Identifiers: NCT02015052, NCT02239471
Other Study ID Numbers: U01DK098245 ( U.S. NIH Grant/Contract )
U01DK098245 ( U.S. NIH Grant/Contract )
First Submitted: August 9, 2013
First Posted: September 16, 2013
Results First Submitted: August 10, 2020
Results First Posted: September 9, 2020
Last Update Posted: September 9, 2020