We are updating the design of this site. Learn more.
Show more
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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01942694
First Posted: September 16, 2013
Last Update Posted: December 14, 2017
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.
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
August 9, 2013
September 16, 2013
December 14, 2017
October 2013
November 2018   (Final data collection date for primary outcome measure)
Time to development of diabetes [ Time Frame: Approximately 48 months ]
Time to development of diabetes [ Time Frame: Every 12 months for approximately 48 months ]
Complete list of historical versions of study NCT01942694 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Variability of response to vitamin D supplementation by baseline characteristic: pre-diabetes criteria (two vs. three criteria) [ Time Frame: Approximately 48 months ]
  • 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 [ 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 ]
  • 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 ]
  • 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. ]
Not Provided
 
Vitamin D and Type 2 Diabetes Study
Vitamin D and Type 2 Diabetes Study
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Prediabetes
  • Type 2 Diabetes
  • 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
  • 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)
Pittas AG, Dawson-Hughes B, Sheehan PR, Rosen CJ, Ware JH, Knowler WC, Staten MA; D2d Research Group. Rationale and design of the Vitamin D and Type 2 Diabetes (D2d) study: a diabetes prevention trial. Diabetes Care. 2014 Dec;37(12):3227-34. doi: 10.2337/dc14-1005. Epub 2014 Sep 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2382
December 2018
November 2018   (Final data collection date for primary outcome measure)

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 22.5 to 42 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.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01942694
U01DK098245( U.S. NIH Grant/Contract )
U01DK098245 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Tufts Medical Center
Tufts Medical Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Office of Dietary Supplements (ODS)
  • American Diabetes Association
Principal Investigator: Anastassios Pittas, MD, MS Tufts Medical Center
Tufts Medical Center
December 2017

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