Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D group | Experimental | Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks |
|
| Placebo group | Placebo Comparator | Placebo, two tablets daily in 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | 2800 IE daily in 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Preoperative P-PTH | Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group. | 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Muscular Function | One Year | |
| Reduced Postoperative Hypocalcemia | Postoperative week | |
| Increase in Quality of Life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lars Rolighed, MD | Principal Investigator | |
| Lars Rejnmark, MD,PhD,DrMed | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osteoporoseklinikken, Aarhus University Hospital, THG | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35018442 | Derived | 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. |
Not provided
Not provided
We screened 227 PHPT patients. A total of 46 patients were included.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks |
| FG001 | Placebo | Placebo, two tablets daily in 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks |
| BG001 | Placebo | Placebo, two tablets daily in 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decrease in Preoperative P-PTH | Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group. | Posted | Mean | Standard Error | pmol/l | 25 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D | Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment | Admission to hospital due to pain and infection from kidney stones. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Upper abdominal self-limitating pain. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lars Rolighed | Aarhus University Hospital | 004520677876 | larsrolighed@gmail.com |
Not provided
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D049950 | Hyperparathyroidism, Primary |
| D006934 | Hypercalcemia |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Improved Muscular Function | Not Posted | One Year |
| Secondary | Reduced Postoperative Hypocalcemia | Not Posted | Postoperative week |
| Secondary | Increase in Quality of Life | Not Posted | One year |
| Secondary | Increased Bone Mineral Density | Not Posted | One year |
| Secondary | Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm | Not Posted | one year |
| 1 |
| 20 |
| 4 |
| 20 |
| EG001 | Placebo | Placebo, two tablets daily in 52 weeks. | 1 | 22 | 6 | 22 |
|
| Eye operation | Eye disorders | Non-systematic Assessment | Admission to hospital for operation at the eye lens. |
|
|
| Steatosis hepatis | Gastrointestinal disorders | Non-systematic Assessment | Diagnosed by chance during examination for kidney stones |
|
| Hand eczema | Skin and subcutaneous tissue disorders | Systematic Assessment | Red eczema on two fingers. |
|
| Eye infection | Eye disorders | Non-systematic Assessment | Local or bilateral eye infection. |
|
| Cystitis | Renal and urinary disorders | Non-systematic Assessment | Symptoms classified and treated as cystitis |
|
| Heamatoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Local heamatoma after tissue biopsy. |
|
| Lower leg cramp | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Pain or cramp in one or both of the lower legs. |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Respiratory infection classified and treated as pneumonia. |
|
| Voice change | Nervous system disorders | Non-systematic Assessment | Temporary voice changes after neck operation for hyperparathyroidism not classified as recurrent laryngeal nerve palsy. |
|
| Changed sense of touch | Nervous system disorders | Non-systematic Assessment | Experience of a change in the sense of touch in face, arms or legs. |
|
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |