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Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Primary Purpose

Vitamin D Deficiency, Primary Hyperparathyroidism, Hypercalcemia

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Primary hyperparathyroidism, hypercalcemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osteoporoseklinikken, Aarhus University Hospital, THG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D group

Placebo group

Arm Description

Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks

Placebo, two tablets daily in 52 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improved Muscular Function
Reduced Postoperative Hypocalcemia
Increase in Quality of Life
Increased Bone Mineral Density
Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm

Full Information

First Posted
May 5, 2008
Last Updated
October 23, 2013
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00674154
Brief Title
Effect of Vitamin D Treatment in Primary Hyperparathyroidism
Official Title
Effect of Vitamin D Treatment in Primary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Primary Hyperparathyroidism, Hypercalcemia
Keywords
Vitamin D, Primary hyperparathyroidism, hypercalcemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D group
Arm Type
Experimental
Arm Description
Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo, two tablets daily in 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
vitamin D
Intervention Description
2800 IE daily in 52 weeks
Primary Outcome Measure Information:
Title
Decrease in Preoperative P-PTH
Description
Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.
Time Frame
25 weeks
Secondary Outcome Measure Information:
Title
Improved Muscular Function
Time Frame
One Year
Title
Reduced Postoperative Hypocalcemia
Time Frame
Postoperative week
Title
Increase in Quality of Life
Time Frame
One year
Title
Increased Bone Mineral Density
Time Frame
One year
Title
Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Rolighed, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Rejnmark, MD,PhD,DrMed
Official's Role
Study Director
Facility Information:
Facility Name
Osteoporoseklinikken, Aarhus University Hospital, THG
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
35018442
Citation
Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
Results Reference
derived

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Effect of Vitamin D Treatment in Primary Hyperparathyroidism

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