Text Size

Effect af Vitamin D Treatment in Primary Hyperparathyroidism

This study is ongoing, but not recruiting participants.
Sponsor:
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
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Decrease in P-PTH [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved muscular function [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Reduced postoperative hypocalcemia [ Time Frame: Postoperative week ] [ Designated as safety issue: No ]
  • Increase in quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Increased bone mineral density [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Increase in trabecular and cortical vBMD measured by QCT and pQCT of hip, spine and forearm [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
 Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Names:
  • cholecalciferol
  • vitamin D
Placebo Comparator: 2
Placebo, two tablets daily in 52 weeks.
 Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Names:
  • cholecalciferol
  • vitamin D

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674154

Locations
Denmark
Osteoporoseklinikken, Aarhus University Hospital, THG
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Lars Rolighed, MD
Study Director: Lars Rejnmark, MD,PhD,DrMed
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00674154     History of Changes
Other Study ID Numbers: PHPT-20080011
Study First Received: May 5, 2008
Last Updated: September 12, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Vitamin D
Primary hyperparathyroidism
hypercalcemia

Additional relevant MeSH terms:
Hypercalcemia
Hyperparathyroidism
Vitamin D Deficiency
Hyperparathyroidism, Primary
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Parathyroid Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
 Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013