Vitamin D for Established Type 2 Diabetes (DDM2)

Tufts University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Cholecalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01736865

DK76092-06

R01DK076092 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 127 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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127 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

One placebo pill daily for 1 year

Treatment:

Drug: Placebo

cholecalciferol

Active Comparator group

Description:

One cholecalciferol pill daily for 1 year

Treatment:

Drug: Cholecalciferol