Effect af Vitamin D Treatment in Primary Hyperparathyroidism
This study is ongoing, but not recruiting participants.
Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00674154
First received: May 5, 2008
Last updated: September 12, 2012
Last verified: September 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 5, 2008 | ||||||||
| Last Updated Date | September 12, 2012 | ||||||||
| Start Date ICMJE | May 2008 | ||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Decrease in P-PTH [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Fall in P-PTH [ Time Frame: One year ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00674154 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect af Vitamin D Treatment in Primary Hyperparathyroidism | ||||||||
| Official Title ICMJE | Effect of Vitamin D Treatment in Primary Hyperparathyroidism | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Names:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | May 2013 | ||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00674154 | ||||||||
| Other Study ID Numbers ICMJE | PHPT-20080011 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of Aarhus | ||||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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