Vitamin D Deficiency Clinical Trial
Official title:
Effect of Vitamin D Treatment in Primary Hyperparathyroidism
The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.
Status | Completed |
Enrollment | 46 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - P-Ca-ion > 1,30 mmol/l - P-PTH > 5 pmol/l - P-OH25-vitamin D < 80 nmol/l Exclusion Criteria: - P-creatinin > 120 mumol/l - usage of Etalpha, Mimpara - Cancer - Sarcoidosis - malabsorption - pancreatitis - alcohol abuse - pregnancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Osteoporoseklinikken, Aarhus University Hospital, THG | Aarhus C |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in Preoperative P-PTH | Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group. | 25 weeks | No |
Secondary | Improved Muscular Function | One Year | No | |
Secondary | Reduced Postoperative Hypocalcemia | Postoperative week | No | |
Secondary | Increase in Quality of Life | One year | No | |
Secondary | Increased Bone Mineral Density | One year | No | |
Secondary | Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm | one year | No |
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