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| Sponsor: | University of Aarhus |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00674154 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
Cholecalciferol 2800 IE pr. dag, 52 uger
|
Drug: Cholecalciferol
2800 IE pr. day in 52 weeks
|
|
2: Placebo Comparator
Placebo
|
Drug: Cholecalciferol
2800 IE pr. day in 52 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Unaffiliated ( Lars Rolighed, MD ) |
| Study ID Numbers: | PHPT-20080011 |
| Study First Received: | May 5, 2008 |
| Last Updated: | October 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00674154 History of Changes |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
|
Vitamin D Primary hyperparathyroidism hypercalcemia |
|
Vitamin D Deficiency Cholecalciferol Parathyroid Diseases Metabolic Diseases Avitaminosis Growth Substances Physiological Effects of Drugs Ergocalciferols Hypercalcemia Endocrine System Diseases Bone Density Conservation Agents |
Pharmacologic Actions Calcium Metabolism Disorders Vitamin D Malnutrition Hyperparathyroidism Vitamins Nutrition Disorders Water-Electrolyte Imbalance Micronutrients Hyperparathyroidism, Primary Deficiency Diseases |