Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Phase 2

Completed

• Conditions: Vitamin D Deficiency; Primary Hyperparathyroidism; Hypercalcemia
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT00674154
• Lead Sponsor: University of Aarhus

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.

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-07
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2013-08-06
• Results First Submitted QC: 2013-08-06
• Results First Posted: 2013-10-16
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Cholecalciferol	Placebo, two tablets daily in 52 weeks.
Vitamin D group	Cholecalciferol	Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks

Primary Outcome Measures

Name	Time	Method
Decrease in Preoperative P-PTH	25 weeks	Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.

Secondary Outcome Measures

Name	Time	Method
Increased Bone Mineral Density	One year
Increase in Quality of Life	One year
Improved Muscular Function	One Year
Reduced Postoperative Hypocalcemia	Postoperative week
Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm	one year

Trial Locations

Locations (1)

Osteoporoseklinikken, Aarhus University Hospital, THG; 🇩🇰 Aarhus C, Denmark