Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01942694
Previous Study | Return to List | Next Study

Vitamin D and Type 2 Diabetes Study (D2d)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 9, 2013
First Posted Date  ICMJE September 16, 2013
Results First Submitted Date  ICMJE August 10, 2020
Results First Posted Date  ICMJE September 9, 2020
Last Update Posted Date September 9, 2020
Study Start Date  ICMJE October 2013
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
Time to Development of Diabetes [ Time Frame: Approximately 48 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
Time to Development of Diabetes [ Time Frame: Every 12 months for approximately 48 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD Concentration [ Time Frame: Approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation) [ Time Frame: Approximately 48 months ]
    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.
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria) [ Time Frame: Approximately 48 months ]
    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).
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI [ Time Frame: Approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference [ Time Frame: Approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age [ Time Frame: Approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure) [ Time Frame: Approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From Supplements [ Time Frame: Approximately 48 months ]
  • Blood Plasma 25OHD Concentration. [ Time Frame: Approximately 48 months ]
  • Number of Participants With Adverse Events. [ Time Frame: Approximately 48 months ]
  • Change in Blood Pressure as a Continuous Variable. [ Time Frame: Approximately 48 months ]
  • Number of Participants Who Discontinue Study Pills. [ Time Frame: Approximately 48 months ]
  • Change in FPG as a Continuous Variable. [ Time Frame: Every 12 months for approximately 48 months ]
  • Change in 2hPG as a Continuous Variable. [ Time Frame: Every 12 months for approximately 48 months. ]
  • Change in HbA1c as a Continuous Variable. [ Time Frame: Every 6 months for approximately 48 months ]
  • Measurement of Insulin Resistance (Derived From the OGTT). [ Time Frame: Every 12 months for approximately 48 months ]
  • Measurement of Beta Cell Secretion (Derived From the OGTT) [ Time Frame: Every 12 months for approximately 48 months ]
  • Identification of Characteristics Associated With the Variability in Achieved 25OHD Concentration. [ Time Frame: Every 12 months for approximately 48 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2013)
  • Measurement of plasma 25OHD concentration. [ Time Frame: Every 12 months for approximately 48 months ]
  • Number of participants with adverse events as a measure of the safety of vitamin D supplementation. [ Time Frame: Every 3 months for approximately 48 months ]
  • Blood Pressure [ Time Frame: Every 6 months for approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI [ Time Frame: Every 12 months for approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference [ Time Frame: Every 12 months for approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Age [ Time Frame: Every 12 months for approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure) [ Time Frame: Every 12 months for approximately 48 months ]
  • Variability of response to vitamin D supplementation by baseline characteristic: calcium intake [ Time Frame: every 12 months for approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD Concentration [ Time Frame: Every 12 months for approximately 48 months ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation) [ Time Frame: Every 12 months for approximately 48 months ]
  • Number of participants who discontinue study pills as a measure of the tolerability of vitamin D supplementation. [ Time Frame: Every 6 months for approximately 48 months. ]
  • Change in FPG as a Continuous Variable. [ Time Frame: Every 6 months for approximately 48 months ]
  • Change in 2hPG as a Continuous Variable. [ Time Frame: Every 12 months for approximately 48 months. ]
  • Measurement of Insulin Resistance (Derived From the OGTT). [ Time Frame: Every 12 months for approximately 48 months ]
  • Measurement of Beta Cell Secretion (Derived From the OGTT) [ Time Frame: Every 12 months for approximately 48 months ]
  • Identification of characteristics associated with the variability in achieved 25-hydroxycholecalciferol (25OHD) concentration. [ Time Frame: Every 12 months for approximately 48 months ]
  • Change in HbA1c as a Continuous Variable. [ Time Frame: Every 6 months for approximately 48 months ]
Current Other Pre-specified Outcome Measures
 (submitted: December 8, 2017)
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Sex [ Time Frame: Approximately 48 months. ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Ethnicity [ Time Frame: Approximately 48 months. ]
  • Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 2 Hour Plasma Glucose [ Time Frame: Approximately 48 months ]
  • Time to Development of Cancer. [ Time Frame: Approximately 48 months. ]
  • Time to Development of Cardiovascular Event. [ Time Frame: Approximately 48 months. ]
  • Incidence of Cancer in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria. [ Time Frame: Approximately 48 months. ]
  • Incidence of Cardiovascular Disease in a Pre-diabetes Population Defined by the Modern American Diabetes Association Criteria. [ Time Frame: Approximately 48 months. ]
  • 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). [ Time Frame: One time assessment at the month 24 visit. ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Type 2 Diabetes Study
Official Title  ICMJE Vitamin D and Type 2 Diabetes Study
Brief Summary The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.
Detailed Description The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism. Researchers at US sites will enroll people with pre-diabetes (people who have higher than normal blood glucose level but not high enough to meet the diagnosis of diabetes). The study will enroll participants over approximately 2 years and participants will be followed for approximately 3 years. Participants will receive either Vitamin D or a placebo by chance. Participants will take 1 pill a day for the duration of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Prediabetes
  • Type 2 Diabetes
Intervention  ICMJE
  • Dietary Supplement: Vitamin D (Cholecalciferol)
    Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.
  • Other: Placebo
    Administered as one soft-gel pill daily by mouth
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    One pill daily
    Intervention: Other: Placebo
  • Active Comparator: Vitamin D (Cholecalciferol)
    One vitamin D pill daily
    Intervention: Dietary Supplement: Vitamin D (Cholecalciferol)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
2423
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2013)
2382
Estimated Study Completion Date  ICMJE May 2021
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the following glycemic criteria at the baseline visit:

    1. Fasting plasma glucose (FPG) 100-125 mg/dL
    2. 2-hour plasma glucose (2hPG) 140-199 mg/dL
    3. Hemoglobin A1c (HbA1c) 5.7-6.4%
  2. Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska Native, Native Hawaiian or Other Pacific Islander).
  3. Body Mass Index ≥ 24.0 (22.5 for Asians) and ≤ 42.0 kg/m2
  4. Provision of signed and dated written informed consent prior to any study procedures.

Major Exclusion Criteria:

  1. Diabetes based on either of the following criteria:

    1. History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes), used for any condition (e.g. pre-diabetes, diabetes, polycystic ovarian syndrome.
    2. Meeting the diagnosis criteria for diabetes
  2. History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.
  3. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.
  4. Currently breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01942694
Other Study ID Numbers  ICMJE U01DK098245( U.S. NIH Grant/Contract )
U01DK098245 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tufts Medical Center
Study Sponsor  ICMJE Tufts Medical Center
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Office of Dietary Supplements (ODS)
  • American Diabetes Association
Investigators  ICMJE
Principal Investigator: Anastassios Pittas, MD, MS Tufts Medical Center
PRS Account Tufts Medical Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP