Trial record 7 of 45 for:    "familial isolated hyperparathyroidism" OR "Hyperparathyroidism, Primary"

Effect of Vitamin D Treatment in Primary Hyperparathyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00674154
First received: May 5, 2008
Last updated: October 23, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Vitamin D Deficiency
Primary Hyperparathyroidism
Hypercalcemia
Drug: Cholecalciferol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Decrease in Preoperative P-PTH [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.


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 ]

Enrollment: 46
Study Start Date: May 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D group
Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks
Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Names:
  • cholecalciferol
  • vitamin D
Placebo Comparator: Placebo group
Placebo, two tablets daily in 52 weeks.
Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Names:
  • cholecalciferol
  • vitamin D

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: August 6, 2013
Last Updated: October 23, 2013
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:
Hyperparathyroidism, Primary
Hypercalcemia
Hyperparathyroidism
Vitamin D Deficiency
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 July 29, 2014