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

  Hide Study Locations
Locations
United States, Arizona
Southwest American Indian Center Not yet recruiting
Phoenix, Arizona, United States, 85016
Contact: Maria Meacham    602-640-2190 ext 204    mmeacham@mail.nih.gov   
Principal Investigator: Jennifer Weil, MD         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90022
Contact: Valerie Ruelas, MSW    323-361-8416    vruelas@usc.edu   
Principal Investigator: Anne Peters, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Josephine Hau, BS, RD    650-427-0785    jhau@standford.edu   
Principal Investigator: Sun H Kim, MD, MS         
United States, Florida
Florida Hospital Translational Research Institute Recruiting
Orlando, Florida, United States, 32804
Contact: Mandy Jones, BS, BSN, RN    407-303-7193    TRI@flhosp.org   
Principal Investigator: Richard E Pratley, MD         
United States, Georgia
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Rincy Varughese, MS    404-235-3024      
Principal Investigator: Lawrence Phillips, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Meg Sullivan, MS    312-503-3413    D2d@northwestern.edu   
Principal Investigator: Lisa Neff, MD, MS         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66205
Contact: Erica Lower, MA    913-588-6052    d2dstudy@kumc.edu   
Principal Investigator: David C Robbins, MD         
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Amy Thomassie, RN, CCRC    225-763-3000    clinicaltrials@pbrc.edu   
Principal Investigator: George Bray, MD         
Tulane University Health Sciences Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Robbin Bye, RN, BSN    504-988-0200    rbye1@tulane.edu   
Principal Investigator: Vivian Fonseca, MD         
United States, Maine
Maine Medical Center Recruiting
Scarborough, Maine, United States, 04074
Contact: Jacki LaPointe, RN    207-661-7624    D2d@mmc.org   
Principal Investigator: Irwin Brodsky, Md, MPH         
United States, Maryland
MedStar Community Clinical Research Center Recruiting
Hyattsville, Maryland, United States, 20782
Contact: Ernest Evans    301-560-2929    studies@medstar.net   
Principal Investigator: Vanita Aroda, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Sarah Gunn, MS    617-636-2834    tufts@d2dstudy.org   
Principal Investigator: Anastassios G Pittas, MD, MS         
United States, Minnesota
Health Partners Riverside Clinic Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Shelly Cook, RN    612-341-1950      
Principal Investigator: Chhavi Chadha, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Grace Rodriguez    402-995-3924    mrodrigu@unmc.edu   
Principal Investigator: Cyrus V Desouza, MBBS         
Omaha VA Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: Rob Heineman    402-995-4873    mrodrigu@unmc.edu   
Principal Investigator: Cyrus Desouza, MBBS         
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Kamala Mantha-Thaler    212-420-3450    kmantha@chpnet.org   
Principal Investigator: Leonid Poretsky, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27704
Contact: Kathy Chmielewski, CMA, CCRP    919-688-7863    D2dstudy@dm.duke.edu   
Principal Investigator: Ranee Chatterjee Montgomery, MD, MPH         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Suzanne Kuker, MA, CCRC    843-792-5427    kuker@musc.edu   
Principal Investigator: Patrick O'Neil, PhD         
United States, Tennessee
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38105
Contact: Lisa Jones, RN    901-448-8400      
Principal Investigator: Karen C Johnson, MD, MPH         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Brenda Brightman    214-342-2383    brenda.brightman@utsouthwestern.edu   
Principal Investigator: Philip Raskin, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Molly Gee, RD    713-798-3741    VitDstudy@bcm.edu   
Principal Investigator: John Foreyt, PhD         
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 17, 2014