Vitamin D for Established Type 2 Diabetes (DDM2)

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Cholecalciferol; Vitamin D

Criteria

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