Vitamin D Supplementation to Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: Placebo
- Registration Number
- NCT00400491
- Lead Sponsor
- University of Tromso
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Cholecalciferol (vitamin D) - 2 Placebo -
- Primary Outcome Measures
Name Time Method glycated hemoglobin 6 months
- Secondary Outcome Measures
Name Time Method body weight 6 months insulin sensitivity 6 months lipids 6 months blood pressure 6 months Hip/waist ratio 6 months Hs-CRP 6 months
Trial Locations
- Locations (1)
Clinical Research Unit, University Hospital of North Norway
🇳🇴Tromsø, Norway