Vitamin D for the Prevention of Diabetes Type 2

University of Tromso (UiT)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Impaired Glucose Tolerance

Treatments: Drug: Placebo; Drug: cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT00685594

UIT-ENDO-2008-1

NFR 184766/V50

Details and patient eligibility

About

The prevalence of type 2 diabetes is increasing, which for most societies has considerable consequences not only regarding health but also economy. Type 2 diabetes develops through a "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change in lifestyle or with medication may prevent such progression. There are indications that vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with vitamin D may improve glucose tolerance and potentially prevent the development of type 2 diabetes in subjects at risk. However, this has so far not been demonstrated in a prospective, randomised clinical study. In the present study we will therefore include 600 subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo for 5 years. A glucose tolerance test will be performed each year, and development of type 2 diabetes will be the main endpoint.

Enrollment: 511 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Impaired glucose tolerance

Exclusion criteria

• Serious heart disease
• Renal stone disease
• Hypercalcemia
• Sarcoidosis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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511 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Cholecalciferol 20.000 IU per week for 5 years

Treatment:

Drug: cholecalciferol

2

Placebo Comparator group

Treatment:

Drug: Placebo