A Phase 2/3 interventional study of Cholecalciferol in Vitamin D Deficiency, Primary Hyperparathyroidism and Hypercalcemia, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-18.
Sponsored by University of Aarhus · Phase 2/3, Interventional, and Treatment
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.
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.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's enrollment of 46 is below the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks
Drug: Cholecalciferol
Placebo, two tablets daily in 52 weeks.
Drug: Cholecalciferol
2800 IE daily in 52 weeks
Also known as: vitamin D
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
Improved Muscular Function
Time frame: One Year
Reduced Postoperative Hypocalcemia
Time frame: Postoperative week
Increase in Quality of Life
Time frame: One year
Increased Bone Mineral Density
Time frame: One year
Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm
Time frame: one year
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.
| Milestone | Vitamin D | Placebo |
|---|---|---|
| Started | 23 | 23 |
| Completed | 20 | 20 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Did not want parathyroidectomy | 0 | 2 |
Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.
| pmol/l | Vitamin D | Placebo |
|---|---|---|
| Decrease in Preoperative P-PTH | -2.2 ± 0.7 | 0.2 ± 1.0 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D | — | 1/20 (5%) | 4/20 (20%) |
| Placebo | — | 1/22 (4.5%) | 6/22 (27.3%) |
| Event | Vitamin D | Placebo |
|---|---|---|
| NephrolithiasisRenal and urinary disorders | 1/20 | 0/22 |
| Eye operationEye disorders | 0/20 | 1/22 |
| Event | Vitamin D | Placebo |
|---|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 2/20 | 0/22 |
| Eye infectionEye disorders | 1/20 | 1/22 |
| CystitisRenal and urinary disorders | 1/20 | 0/22 |
| Lower leg crampMusculoskeletal and connective tissue disorders | 1/20 | 1/22 |
| Abdominal painGastrointestinal disorders | 0/20 | 1/22 |
| Steatosis hepatisGastrointestinal disorders | 0/20 | 1/22 |
| Hand eczemaSkin and subcutaneous tissue disorders | 0/20 | 1/22 |
| HeamatomaSkin and subcutaneous tissue disorders | 0/20 | 1/22 |
| Voice changeNervous system disorders | 0/20 | 1/22 |
| Changed sense of touchNervous system disorders | 0/20 | 1/22 |
| Age, Categorical(Participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 14 | 30 |
| >=65 years | 7 | 9 | 16 |
| Age Continuous(years) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Mean | 58 ± 14 | 57 ± 13 | 58 ± 13 |
| Sex: Female, Male(Participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Female | 16 | 19 | 35 |
| Male | 7 | 4 | 11 |
| Region of Enrollment(participants) | Vitamin D | Placebo | Total |
|---|---|---|---|
| Denmark | 23 | 23 | 46 |
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol