Hypercalcemia, Primary Hyperparathyroidism, Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Primary hyperparathyroidism, hypercalcemia
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.
Interventions
DRUGCholecalciferol
2800 IE daily in 52 weeks
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Improved Muscular Function | One Year |
| Reduced Postoperative Hypocalcemia | Postoperative week |
| Increase in Quality of Life | One year |
| Increased Bone Mineral Density | One year |
| Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm | one year |
Countries
Denmark
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 details
We screened 227 PHPT patients. A total of 46 patients were included.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks | 23 |
| Placebo Placebo, two tablets daily in 52 weeks. | 23 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not want parathyroidectomy | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Vitamin D | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Age Continuous | 58 years STANDARD_DEVIATION 14 | 57 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 13 |
| Region of Enrollment Denmark | 23 participants | 23 participants | 46 participants |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 20 | 6 / 22 |
| serious Total, serious adverse events | 1 / 20 | 1 / 22 |
Outcome results
Primary
Decrease in Preoperative P-PTH
Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.
Time frame: 25 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D | Decrease in Preoperative P-PTH | -2.2 pmol/l | Standard Error 0.7 |
| Placebo | Decrease in Preoperative P-PTH | 0.2 pmol/l | Standard Error 1 |
Secondary
Improved Muscular Function
Time frame: One Year
Secondary
Increased Bone Mineral Density
Time frame: One year
Secondary
Increase in Quality of Life
Time frame: One year
Secondary
Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm
Time frame: one year
Secondary
Reduced Postoperative Hypocalcemia
Time frame: Postoperative week