Vitamin D Supplementation to Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
University of Tromso
ClinicalTrials.gov Identifier:
NCT00400491
First received: November 16, 2006
Last updated: May 22, 2008
Last verified: May 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014