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Vitamin D for Established Type 2 Diabetes (DDM2) (DDM2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736865
First Posted: November 29, 2012
Last Update Posted: June 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center
November 15, 2012
November 29, 2012
June 10, 2016
December 2012
August 2015   (Final data collection date for primary outcome measure)
Disposition index [ Time Frame: 6 months ]
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 ]
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 ]
  • Change in diabetes medications [ Time Frame: 6 and 12 months ]
  • Variability of response to vitamin D supplementation in subgroups. [ Time Frame: 6 and 12 months ]
    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 ]
  • Cardiovascular risk factors [ Time Frame: 6 and 12 months ]
    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)
Vitamin D for Established Type 2 Diabetes (DDM2)
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Alzaman NS, Dawson-Hughes B, Nelson J, D'Alessio D, Pittas AG. Vitamin D status of black and white Americans and changes in vitamin D metabolites after varied doses of vitamin D supplementation. Am J Clin Nutr. 2016 Jul;104(1):205-14. doi: 10.3945/ajcn.115.129478. Epub 2016 May 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
August 2015
August 2015   (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
Sexes Eligible for Study: All
25 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01736865
DK76092-06
R01DK076092 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Tufts Medical Center
Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Tufts Medical Center
June 2016

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