Vitamin D Supplementation to Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
University of Tromso
Information provided by:
University of Tromso
ClinicalTrials.gov Identifier:
NCT00400491
First received: November 16, 2006
Last updated: May 22, 2008
Last verified: May 2008
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vitamin D Supplementation to Patients With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by University of Tromso:
Primary Outcome Measures:
- glycated hemoglobin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- body weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Hip/waist ratio [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Hs-CRP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: 1 |
Drug: Cholecalciferol (vitamin D)
Cholecalciferol capsule 20.000 IU twice per week for 6 months
Other Name: vitamin D
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo capsule twice a week, identical to the cholecalciferol capsules
Other Name: Placebo
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400491
Locations
| Norway | |
| Clinical Research Unit, University Hospital of North Norway | |
| Tromsø, Norway, 9038 | |
Sponsors and Collaborators
University of Tromso
Investigators
| Principal Investigator: | Rolf Jorde, Professor | University of Tromsø, Tromsø |
More Information
No publications provided
| Responsible Party: | Professor Roy Bremnes, University of Tromso |
| ClinicalTrials.gov Identifier: | NCT00400491 History of Changes |
| Other Study ID Numbers: | EUDRACT-2006-000177-30 |
| Study First Received: | November 16, 2006 |
| Last Updated: | May 22, 2008 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by University of Tromso:
|
diabetes insulin glycated hemoglobin cholecalciferol vitamin D |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 19, 2013