Vitamin D Deficiency Clinical Trial
Official title:
Vitamin D and Chronic Renal Insufficiency
Purpose of this study is to investigate the effect of treatment with vitamin D3 (cholecalciferol) compared with placebo in a trial including chronic kidney disease patients with vitamin D deficiency.
Status | Completed |
Enrollment | 56 |
Est. completion date | January 2011 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Chronic kidney disease (CKD 3-5 amd renal transplanted patients) - Age > 18 years - Vitamin D insufficiency or deficiency (25-OHD < 50 nmol/l, 3 months before project start) Exclusion Criteria: - Treatment with vitamin D2/D3 (dose more than 10000 IU within the last 3 months) - Hypercalcaemia (ca++ > 1,35 mmol/l more than 4 weeks despite missing intake of calcium containing preparations and activated vitamin D) - Uncontrolled hyperphosphataemia (s-phosphate > 2,2 mmol/l) - Sarcoidosis - Malignant disease - Psychotic disorders - Pregnancy and lactation women - Allergy to soya and peanut |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Calcium phosphate associated metabolites, bone markers, endothelial markers, inflammation muscle function, pulse wave velocity test | 8 weeks | Yes | |
Secondary | Health questionnaire | 8 weeks | No |
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