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Vitamin D Supplementation to Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00400491
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : May 23, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Cholecalciferol (vitamin D) Drug: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation to Patients With Type 2 Diabetes
Study Start Date : June 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. glycated hemoglobin [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 6 months ]
  2. body weight [ Time Frame: 6 months ]
  3. Hip/waist ratio [ Time Frame: 6 months ]
  4. lipids [ Time Frame: 6 months ]
  5. Hs-CRP [ Time Frame: 6 months ]
  6. insulin sensitivity [ Time Frame: 6 months ]


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Professor Roy Bremnes, University of Tromso
ClinicalTrials.gov Identifier: NCT00400491     History of Changes
Other Study ID Numbers: EUDRACT-2006-000177-30
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 2008

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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents