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 currently recruiting participants. (see Contacts and Locations)
Verified June 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: June 17, 2014
Last verified: June 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 .(≥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
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, see Learn About Clinical Studies.

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: Jennifer Lewandowski    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 Active, not recruiting
New Orleans, Louisiana, United States, 70112
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: Jeff Newcomb, B.S; E.M.T    402-559-6279    jeff.newcomb@unmc.edu   
Principal Investigator: Cyrus V Desouza, MBBS         
Omaha VA Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: Jeff Newcomb, B.S; E.M.T    402-995-3924    jeff.newcomb@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: June 17, 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 July 23, 2014