Effect of Vitamin D Treatment in Primary Hyperparathyroidism

October 23, 2013 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Osteoporoseklinikken, Aarhus University Hospital, THG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D group
Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks
Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Names:
  • vitamin D
Placebo Comparator: Placebo group
Placebo, two tablets daily in 52 weeks.
Drug: Cholecalciferol
2800 IE daily in 52 weeks
Other Names:
  • vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in Preoperative P-PTH
Time Frame: 25 weeks
Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.
25 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHPT-20080011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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