Effect of Vitamin D Treatment in Primary Hyperparathyroidism

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00674154
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 63
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency; Primary Hyperparathyroidism; Hypercalcemia	Drug: Cholecalciferol	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Vitamin D Treatment in Primary Hyperparathyroidism
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Improved Muscular Function [One Year]

2. Reduced Postoperative Hypocalcemia [Postoperative week]

3. Increase in Quality of Life [One year]

4. Increased Bone Mineral Density [One year]

5. Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Osteoporoseklinikken, Aarhus University Hospital, THG	Aarhus C		Denmark	8000

Sponsors and Collaborators

• University of Aarhus

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT00674154
• Other Study ID Numbers: PHPT-20080011
• First Posted: May 7, 2008
• Last Update Posted: Nov 18, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by University of Aarhus: Vitamin D; Primary hyperparathyroidism; hypercalcemia
• Additional relevant MeSH terms: Vitamin D Deficiency; Hypercalcemia; Hyperparathyroidism; Hyperparathyroidism, Primary; Vitamin D; Cholecalciferol

Study Results

Participant Flow

Recruitment Details	We randomized 46 patients with PHPT and 25OHD-levels < 80 nmol/l to a daily supplement with 70 microgram (2800 IU) of cholecalciferol or identical placebo for 52 weeks. Accordingly, treatment was administered for 26 weeks prior to parathyroidectomy and continued for 26 weeks following surgical cure.
Pre-assignment Detail	We screened 227 PHPT patients. A total of 46 patients were included.

Arm/Group Title	Vitamin D	Placebo
Arm/Group Description	Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo, two tablets daily in 52 weeks.
Period Title: Overall Study
STARTED	23	23
COMPLETED	20	20
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Vitamin D	Placebo	Total
Arm/Group Description	Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo, two tablets daily in 52 weeks.	Total of all reporting groups
Overall Participants	23	23	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 69.6%	14 60.9%	30 65.2%
>=65 years	7 30.4%	9 39.1%	16 34.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (14)	57 (13)	58 (13)
Sex: Female, Male (Count of Participants)
Female	16 69.6%	19 82.6%	35 76.1%
Male	7 30.4%	4 17.4%	11 23.9%
Region of Enrollment (participants) [Number]
Denmark	23 100%	23 100%	46 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin D	Placebo
Arm/Group Description	Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo, two tablets daily in 52 weeks.
Measure Participants	20	22
Mean (Standard Error) [pmol/l]	-2.2 (0.7)	0.2 (1.0)

2. Secondary Outcome

Title	Improved Muscular Function
Time Frame	One Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Reduced Postoperative Hypocalcemia
Time Frame	Postoperative week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Increase in Quality of Life
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Increased Bone Mineral Density
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Vitamin D		Placebo
Arm/Group Description	Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks		Placebo, two tablets daily in 52 weeks.
All Cause Mortality
	Vitamin D		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vitamin D		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		1/22 (4.5%)
Eye disorders
Eye operation	0/20 (0%)	0	1/22 (4.5%)	1
Renal and urinary disorders
Nephrolithiasis	1/20 (5%)	1	0/22 (0%)	0
Other (Not Including Serious) Adverse Events
	Vitamin D		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/20 (20%)		6/22 (27.3%)
Eye disorders
Eye infection	1/20 (5%)	1	1/22 (4.5%)	1
Gastrointestinal disorders
Abdominal pain	0/20 (0%)	0	1/22 (4.5%)	1
Steatosis hepatis	0/20 (0%)	0	1/22 (4.5%)	1
Musculoskeletal and connective tissue disorders
Lower leg cramp	1/20 (5%)	1	1/22 (4.5%)	1
Nervous system disorders
Voice change	0/20 (0%)	0	1/22 (4.5%)	1
Changed sense of touch	0/20 (0%)	0	1/22 (4.5%)	1
Renal and urinary disorders
Cystitis	1/20 (5%)	1	0/22 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonia	2/20 (10%)	2	0/22 (0%)	0
Skin and subcutaneous tissue disorders
Hand eczema	0/20 (0%)	0	1/22 (4.5%)	1
Heamatoma	0/20 (0%)	0	1/22 (4.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.