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Sponsored by: |
University of Tromso |
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Information provided by: | University of Tromso |
ClinicalTrials.gov Identifier: | NCT00400491 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Drug: Cholecalciferol (vitamin D) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Vitamin D Supplementation to Patients With Type 2 Diabetes |
Enrollment: | 40 |
Study Start Date: | June 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Cholecalciferol (vitamin D)
Cholecalciferol capsule 20.000 IU twice per week for 6 months
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2: Placebo Comparator |
Drug: Placebo
Placebo capsule twice a week, identical to the cholecalciferol capsules
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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.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Clinical Research Unit, University Hospital of North Norway | |
Tromsø, Norway, 9038 |
Principal Investigator: | Rolf Jorde, Professor | University of Tromsø, Tromsø |
Responsible Party: | University of Tromso ( Professor Roy Bremnes ) |
Study ID Numbers: | EUDRACT-2006-000177-30 |
Study First Received: | November 16, 2006 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00400491 History of Changes |
Health Authority: | Norway: Norwegian Medicines Agency |
diabetes insulin glycated hemoglobin cholecalciferol vitamin D |
Cholecalciferol Metabolic Diseases Ergocalciferol Diabetes Mellitus Ergocalciferols Endocrine System Diseases Bone Density Conservation Agents Trace Elements Insulin Vitamin D |
Vitamin D2 Vitamin D3 Vitamins Diabetes Mellitus, Type 2 Calciferol Micronutrients Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Cholecalciferol Metabolic Diseases Growth Substances Physiological Effects of Drugs Diabetes Mellitus Ergocalciferols Endocrine System Diseases |
Bone Density Conservation Agents Pharmacologic Actions Vitamin D Vitamins Diabetes Mellitus, Type 2 Micronutrients Glucose Metabolism Disorders |