Vitamin D Supplementation to Patients With Type 2 Diabetes

University of Tromso (UiT)

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Cholecalciferol (vitamin D)

Study type: Interventional

Funder types: Other

Identifiers

NCT00400491

EUDRACT-2006-000177-30

Details and patient eligibility

About

The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.

Full description

The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.

We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. Only subjects using insulin at bedtime combined with metformin during the day will be included.

Enrollment: 40 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 1 year
• age 21-75 years
• long-acting insulin at bedtime
• metformin during the day
• for women of child bearing age use of reliable method of birth control

Exclusion criteria

• serum creatinine above 130 umol/l for men and above 110 for women
• systolic blood pressure > 175 or diastolic > 104 mmHg
• heart disease
• serum calcium > 2.54 mmol/l
• history of renal stones

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Cholecalciferol (vitamin D)

2

Placebo Comparator group

Treatment:

Drug: Placebo