Vitamin D for Established Type 2 Diabetes (DDM2)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

One placebo pill daily for 1 year

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

cholecalciferol

One cholecalciferol pill daily for 1 year

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

Interventions

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Cholecalciferol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No