Vitamin D for Established Type 2 Diabetes (DDM2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Tufts Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01736865
First received: November 15, 2012
Last updated: May 24, 2013
Last verified: May 2013

November 15, 2012
May 24, 2013
December 2012
December 2016   (final data collection date for primary outcome measure)
Disposition index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Disposition index by the insulin secretion sensitivity index-2 (ISSI-2)
Same as current
Complete list of historical versions of study NCT01736865 on ClinicalTrials.gov Archive Site
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.
Same as current
  • 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
Same as current
 
Vitamin D for Established Type 2 Diabetes (DDM2)
Not Provided

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Cholecalciferol
  • Drug: Placebo
  • Placebo Comparator: placebo
    One placebo pill daily for 1 year
    Intervention: Drug: Placebo
  • Active Comparator: cholecalciferol
    One cholecalciferol pill daily for 1 year
    Intervention: Drug: Cholecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
Not Provided
December 2016   (final data collection date for primary outcome measure)

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
Both
25 Years to 75 Years
No
United States
 
NCT01736865
DK76092-06, R01DK076092
Yes
Tufts Medical Center
Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Tufts Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP