Effect af Vitamin D Treatment in Primary Hyperparathyroidism - Full Text View

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

Resource links provided by NLM:

Drug Information available for: Cholecalciferol 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:	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

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

Contacts

Contact: Lars Rolighed, MD		lars.rolighed@ki.au.dk
Contact: Lars Rejnmark, MD,PhD,DrMed		rejnmark@post6.tele.dk

Locations

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

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:	Lars Rolighed, MD	Unaffiliated
Study Director:	Lars Rejnmark, MD,PhD,DrMed	Unaffiliated

More Information

No publications provided

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

Keywords provided by University of Aarhus:

Vitamin D
Primary hyperparathyroidism
hypercalcemia

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 04, 2010