Vitamin D for Established Type 2 Diabetes (DDM2)

This study is currently recruiting participants.
Verified May 2013 by Tufts Medical Center
Information provided by (Responsible Party):
Tufts Medical Center Identifier:
First received: November 15, 2012
Last updated: May 24, 2013
Last verified: May 2013

This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).

Condition Intervention Phase
Type 2 Diabetes
Drug: Cholecalciferol
Drug: Placebo
Phase 2
Phase 3

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: Treatment

Resource links provided by NLM:

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Disposition index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Disposition index by the insulin secretion sensitivity index-2 (ISSI-2)

Secondary Outcome Measures:
  • Change in glycemia [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Change in glycemia (categorical variable, composite outcome) defined as [1] a decrease in diabetes medications or [2] a reduction of equal to or more than 0.4 HbA1c units from baseline without increasing medications.

Other Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Change in diabetes medications [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Variability of response to vitamin D supplementation in subgroups. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Variability of response to vitamin D supplementation in subgroups defined by baseline characteristics: (1) race; (3) 25OHD concentration; (3) diabetes treatment.

  • Effect of vitamin D supplementation on blood 25-hydroxyvitaminD concentration [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Cardiovascular risk factors [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Cardiovascular risk factors defined as blood pressure, lipid profile, C-reactive protein and urine albumin excretion

Estimated Enrollment: 124
Study Start Date: December 2012
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
One placebo pill daily for 1 year
Drug: Placebo
Active Comparator: cholecalciferol
One cholecalciferol pill daily for 1 year
Drug: Cholecalciferol


Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Established type 2 diabetes, defined by one of the following two criteria:
  • Age ≥ 25 years and ≤ 75 years
  • BMI: 23 to 40 kg/m2 inclusive
  • Provision of signed and dated written informed consent prior to any study procedures.

Major Exclusion Criteria

  • "Severe" diabetes defined by one of the following criteria:
  • - (a) Symptoms of hyperglycemia;
  • - (b) Screening HbA1c ≥ 7.5 [may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy]
  • History of nephrolithiasis or hypercalcemia
  Contacts and Locations
Please refer to this study by its identifier: NCT01736865

United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Paul Fuss    617-636-2834   
Principal Investigator: Anastassios Pittas, MD MS         
United States, Ohio
Cincinnati VA Medical Center Recruiting
Cincinnati, Ohio, United States
Contact: Colleen Rogge    513-475-6478   
Principal Investigator: David D'Alessio, MD         
Sponsors and Collaborators
Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center Identifier: NCT01736865     History of Changes
Other Study ID Numbers: DK76092-06, R01DK076092
Study First Received: November 15, 2012
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents processed this record on April 17, 2014