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Effect of Vitamin D Treatment in Primary Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT00674154
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : October 16, 2013
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Primary Hyperparathyroidism Hypercalcemia Drug: Cholecalciferol Phase 2 Phase 3

Detailed Description:
The study investigates effects and safety of six months of vitamin D supplementation before and after surgery in primary hyperparathyroidism. Effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Treatment in Primary Hyperparathyroidism
Study Start Date : May 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin D group
Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks
 Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Name: vitamin D
Placebo Comparator: Placebo group
Placebo, two tablets daily in 52 weeks.
 Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Name: vitamin D


Outcome Measures
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Primary Outcome Measures :
  1. Decrease in Preoperative P-PTH [ Time Frame: 25 weeks ]
    Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.


Secondary Outcome Measures :
  1. Improved Muscular Function [ Time Frame: One Year ]
  2. Reduced Postoperative Hypocalcemia [ Time Frame: Postoperative week ]
  3. Increase in Quality of Life [ Time Frame: One year ]
  4. Increased Bone Mineral Density [ Time Frame: One year ]
  5. Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674154


Locations
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Denmark
Osteoporoseklinikken, Aarhus University Hospital, THG
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Lars Rolighed, MD
Study Director: Lars Rejnmark, MD,PhD,DrMed
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00674154    
Other Study ID Numbers: PHPT-20080011
First Posted: May 7, 2008    Key Record Dates
Results First Posted: October 16, 2013
Last Update Posted: November 18, 2013
Last Verified: August 2013
Keywords provided by University of Aarhus:
Vitamin D
Primary hyperparathyroidism
hypercalcemia
Additional relevant MeSH terms:
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Vitamin D Deficiency
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases
 Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents