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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
  Purpose
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.

Condition Intervention
Prediabetes Type 2 Diabetes Dietary Supplement: Vitamin D (Cholecalciferol) Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D and Type 2 Diabetes Study

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Time to development of diabetes [ Time Frame: Approximately 48 months ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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. ]

Enrollment: 2382
Study Start Date: October 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
One pill daily
Other: Placebo
Administered as one soft-gel pill daily by mouth
Active Comparator: Vitamin D (Cholecalciferol)
One vitamin D pill daily
Dietary Supplement: Vitamin D (Cholecalciferol)
Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942694


  Show 25 Study Locations
Sponsors and Collaborators
Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Dietary Supplements (ODS)
American Diabetes Association
Investigators
Principal Investigator: Anastassios Pittas, MD, MS Tufts Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01942694     History of Changes
Obsolete Identifiers: NCT02015052, NCT02239471
Other Study ID Numbers: U01DK098245 ( U.S. NIH Grant/Contract )
First Submitted: August 9, 2013
First Posted: September 16, 2013
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by Tufts Medical Center:
Prediabetes
Vitamin D

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents