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Sponsored by: |
University of Aarhus |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00674154 |
The primary aim of the study is to assess whether 6-months of vitamin D supplements prior to surgery decreases the risk of postoperative hypocalcaemia in patients with PHPT. Secondary endpoints include effects of vitamin D supplements on bone turnover, BMD, quality of life, overall well-being, and muscle function.
Condition | Intervention | Phase |
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Vitamin D Deficiency Primary Hyperparathyroidism Hypercalcemia |
Drug: Cholecalciferol |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Effect of Vitamin D Treatment in Primary Hyperparathyroidism |
Estimated Enrollment: | 50 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cholecalciferol 2800 IE pr. dag, 52 uger
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Drug: Cholecalciferol
2800 IE pr. day in 52 weeks
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2: Placebo Comparator
Placebo
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Drug: Cholecalciferol
2800 IE pr. day in 52 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lars Rolighed, MD | lars.rolighed@ki.au.dk | |
Contact: Lars Rejnmark, MD,PhD,DrMed | rejnmark@post6.tele.dk |
Denmark | |
Osteoporoseklinikken, Aarhus University Hospital, THG | Recruiting |
Aarhus C, Denmark, 8000 | |
Contact: Lars Rolighed, MD lars.rolighed@ki.au.dk | |
Contact: Lars Rejnmark, MD, PhD rejnmark@post6.tele.dk | |
Principal Investigator: Lars Rolighed, MD | |
Sub-Investigator: Lars Rejnmark, MD,PhD,DrMed | |
Sub-Investigator: Peter Vestergaard, MD,PhD,DrMed |
Principal Investigator: | Lars Rolighed, MD | Unaffiliated |
Study Director: | Lars Rejnmark, MD,PhD,DrMed | Unaffiliated |
Responsible Party: | Unaffiliated ( Lars Rolighed, MD ) |
Study ID Numbers: | PHPT-20080011 |
Study First Received: | May 5, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00674154 |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Vitamin D Primary hyperparathyroidism hypercalcemia |
Vitamin D Deficiency Cholecalciferol Parathyroid Diseases Metabolic Diseases Avitaminosis Hyperparathyroidism, primary Ergocalciferols Hypercalcemia Endocrine System Diseases |
Vitamin D Malnutrition Hyperparathyroidism Nutrition Disorders Water-Electrolyte Imbalance Endocrinopathy Metabolic disorder Hyperparathyroidism, Primary Deficiency Diseases |
Calcium Metabolism Disorders Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |