Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Vitamin D Deficiency Clinical Trial

Official title:

Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674154
• Other study ID #: PHPT-20080011
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 5, 2008
• Last updated: October 23, 2013
• Start date: May 2008
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercalcemia
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
2800 IE daily in 52 weeks

Locations

Country	Name	City	State
Denmark	Osteoporoseklinikken, Aarhus University Hospital, THG	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Preoperative P-PTH	Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.	25 weeks	No
Secondary	Improved Muscular Function		One Year	No
Secondary	Reduced Postoperative Hypocalcemia		Postoperative week	No
Secondary	Increase in Quality of Life		One year	No
Secondary	Increased Bone Mineral Density		One year	No
Secondary	Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm		one year	No