Vitamin D Supplementation to Patients With Type 2 Diabetes - Full Text View

Sponsored by:	University of Tromso
Information provided by:	University of Tromso
ClinicalTrials.gov Identifier:	NCT00400491

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 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Dietary Supplements

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

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
1: Experimental	Drug: Cholecalciferol (vitamin D) Cholecalciferol capsule 20.000 IU twice per week for 6 months
2: Placebo Comparator	Drug: Placebo Placebo capsule twice a week, identical to the cholecalciferol capsules

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:	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

Keywords provided by University of Tromso:

diabetes
insulin
glycated hemoglobin
cholecalciferol
vitamin D

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 03, 2009