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

This study is currently recruiting participants.
Verified February 2014 by Tufts Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01942694
First received: August 9, 2013
Last updated: February 19, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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: Every 12 months for approximately 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of plasma 25OHD concentration. [ Time Frame: Every 12 months for approximately 48 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Every 6 months for approximately 48 months ] [ Designated as safety issue: No ]
  • Variability of response to vitamin D supplementation by baseline characteristic: BMI [ Time Frame: Every 12 months for approximately 48 months ] [ Designated as safety issue: No ]
  • Variability of response to vitamin D supplementation by baseline characteristic: waist circumference [ Time Frame: Every 12 months for approximately 48 months ] [ Designated as safety issue: No ]
  • Variability of response to vitamin D supplementation by baseline characteristic: age [ Time Frame: Every 12 months for approximately 48 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Variability of response to vitamin D supplementation by baseline characteristic: calcium intake [ Time Frame: every 12 months for approximately 48 months ] [ Designated as safety issue: No ]
  • Variability of response to vitamin D supplementation by baseline characteristic: 25OHD concentration [ Time Frame: Every 12 months for approximately 48 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Change in FPG as a continuous variable. [ Time Frame: Every 6 months for approximately 48 months ] [ Designated as safety issue: No ]
  • Change in 2hPG as a continuous variable. [ Time Frame: Every 12 months for approximately 48 months. ] [ Designated as safety issue: No ]
  • Measurement of insulin resistance (derived from the OGTT). [ Time Frame: Every 12 months for approximately 48 months ] [ Designated as safety issue: No ]
  • Measurement of beta cell secretion (derived from the OGTT) [ Time Frame: Every 12 months for approximately 48 months ] [ Designated as safety issue: Yes ]
  • Identification of characteristics associated with the variability in achieved 25-hydroxycholecalciferol (25OHD) concentration. [ Time Frame: Every 12 months for approximately 48 months ] [ Designated as safety issue: No ]
  • Change in HbA1c as a continuous variable. [ Time Frame: Every 6 months for approximately 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2382
Study Start Date: October 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (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 twenty 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 4 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. Participants will visit the study site for up to 13 scheduled visits during their participation.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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.
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942694

  Show 21 Study Locations
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Anastassios Pittas, MD, MS Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01942694     History of Changes
Other Study ID Numbers: U01DK098245, U01DK098245
Study First Received: August 9, 2013
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Tufts Medical Center:
Prediabetes
Vitamin D

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

ClinicalTrials.gov processed this record on April 22, 2014