Trial Outcomes & Findings for Effect of Vitamin D Treatment in Primary Hyperparathyroidism (NCT NCT00674154)

NCT ID: NCT00674154

Last Updated: 2013-11-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 46 participants
• Primary outcome timeframe: 25 weeks
• Results posted on: 2013-11-18

Participant Flow

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.

We screened 227 PHPT patients. A total of 46 patients were included.

Participant milestones

Measure	Vitamin D Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo Placebo, two tablets daily in 52 weeks.
Overall Study STARTED	23	23
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Vitamin D Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo Placebo, two tablets daily in 52 weeks.
Overall Study Withdrawal by Subject	3	1
Overall Study Did not want parathyroidectomy	0	2

Baseline Characteristics

Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Baseline characteristics by cohort

Measure	Vitamin D n=23 Participants Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo n=23 Participants Placebo, two tablets daily in 52 weeks.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age Continuous	58 years STANDARD_DEVIATION 14 • n=5 Participants	57 years STANDARD_DEVIATION 13 • n=7 Participants	58 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Denmark	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 25 weeks

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

Outcome measures

Measure	Vitamin D n=20 Participants Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo n=22 Participants Placebo, two tablets daily in 52 weeks.
Decrease in Preoperative P-PTH	-2.2 pmol/l Standard Error 0.7	0.2 pmol/l Standard Error 1.0

SECONDARY outcome

Timeframe: One Year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Postoperative week

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome data not reported

Adverse Events

Vitamin D

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vitamin D n=20 participants at risk Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo n=22 participants at risk Placebo, two tablets daily in 52 weeks.
Renal and urinary disorders Nephrolithiasis	5.0% 1/20 • Number of events 1	0.00% 0/22
Eye disorders Eye operation	0.00% 0/20	4.5% 1/22 • Number of events 1

Other adverse events

Measure	Vitamin D n=20 participants at risk Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks	Placebo n=22 participants at risk Placebo, two tablets daily in 52 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/20	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Steatosis hepatis	0.00% 0/20	4.5% 1/22 • Number of events 1
Skin and subcutaneous tissue disorders Hand eczema	0.00% 0/20	4.5% 1/22 • Number of events 1
Eye disorders Eye infection	5.0% 1/20 • Number of events 1	4.5% 1/22 • Number of events 1
Renal and urinary disorders Cystitis	5.0% 1/20 • Number of events 1	0.00% 0/22
Skin and subcutaneous tissue disorders Heamatoma	0.00% 0/20	4.5% 1/22 • Number of events 1
Musculoskeletal and connective tissue disorders Lower leg cramp	5.0% 1/20 • Number of events 1	4.5% 1/22 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	10.0% 2/20 • Number of events 2	0.00% 0/22
Nervous system disorders Voice change	0.00% 0/20	4.5% 1/22 • Number of events 1
Nervous system disorders Changed sense of touch	0.00% 0/20	4.5% 1/22 • Number of events 1

Additional Information

Lars Rolighed

Aarhus University Hospital

Phone: 004520677876

Email: larsrolighed@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place