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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK084986-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.
Primary hyperparathyroidism (PHPT) is a common disease in which the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. In primary hyperparathyroidism, high levels of PTH remove too much calcium from bones and deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by the excess calcium loss which weakens the structure of the bones.
Many patients with primary hyperparathyroidism also have low vitamin D (25OHD) levels which is thought to further impair bone health. Recent medical guidelines recommend treating patients with primary hyperparathyroidism who have low vitamin D levels with oral vitamin D but the optimal vitamin D dose and rate of repletion is unclear. It is, therefore, important to determine if replenishing Vitamin D will improve bone health in primary hyperparathyroidism, and if so, to assess the impact of the rate of vitamin D repletion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D |
|
| Group 2 | Placebo Comparator | Placebo plus a multivitamin with 400 IU vitamin D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10,000 IU Vitamin D3 | Drug | Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Parathyroid Hormone (PTH) Level | This is designed to measure how many participants will achieve PTH > 65 pg/mL. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Areal Bone Mineral Density of the Lumbar Spine | Measured by dual-energy x-ray absorptiometry (DEXA) scan | 6 months |
| Trabecular Bone Density at the Forearm | Measured by high resolution peripheral quantitative computed tomography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shonni J Silverberg, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 10,000 IU Vitamin D3 + Multivitamin | 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D. |
| FG001 | Placebo + Multivitamin | Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10,000 IU Vitamin D3 + Multivitamin | 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D. |
| BG001 | Placebo + Multivitamin |
| 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 | Serum Parathyroid Hormone (PTH) Level | This is designed to measure how many participants will achieve PTH > 65 pg/mL. | Study enrollment did not reach the required number of subjects; the analysis results would not have been reliable or have enough statistical power. Therefore, samples were not processed and data was not available for analysis. | Posted | 6 months |
|
6 months
Definitions do not differ from those of the ClinicalTrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Renal and urinary disorders | Systematic Assessment | Urinary infection - E. Coli |
Study enrollment did not reach the required number of subjects; the analysis results would not have been reliable or have enough statistical power. Therefore, samples were not processed and data was not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shonni Silverberg, MD | Columbia University | 212-305-6291 | sjs7@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2015 | Aug 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D014808 | Vitamin D Deficiency |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001361 | Avitaminosis |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Active arm:
Month 1: 20,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D.
Months 2-6: 10,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D.
Placebo arm:
Month 1: Placebo once a week plus daily multivitamin with 400 IU vitamin D.
Months 2-6: Placebo every week plus daily multivitamin with 400 IU vitamin D.
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Patient, investigator and study team will be blinded to study arm ramdomization.
| Placebo | Other | Month 1: Placebo once a week Months 2-6: Placebo once a week |
|
|
| Vitamin D | Dietary Supplement | Daily multivitamin with 400 IU vitamin D. |
|
|
| 6 months |
| Change in Urinary Calcium Level | This is designed to measure how the study treatment will affect urinary calcium level over time. | 1 month, 3 months, 6 months |
Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Placebo plus a multivitamin with 400 IU vitamin D
Placebo: Month 1: Placebo once a week
Months 2-6: Placebo once a week
Vitamin D: Daily multivitamin with 400 IU vitamin D.
|
| Secondary | Areal Bone Mineral Density of the Lumbar Spine | Measured by dual-energy x-ray absorptiometry (DEXA) scan | Study enrollment did not reach the required number of subjects; the analysis results are not reliable or have enough statistical power. | Posted | Mean | Standard Deviation | percentage of change | 6 months |
|
|
|
| Secondary | Trabecular Bone Density at the Forearm | Measured by high resolution peripheral quantitative computed tomography | Study enrollment did not reach the required number of subjects; the analysis results are not reliable nor have enough statistical power. | Posted | Mean | Standard Deviation | percentage of change | 6 months |
|
|
|
| Secondary | Change in Urinary Calcium Level | This is designed to measure how the study treatment will affect urinary calcium level over time. | Data is provided for 6 out of the 7 participants in Group 1 due to that 1 participant became lost to follow-up and did not complete lab testing at Month 3 and 6. | Posted | Mean | Full Range | mg/day | 1 month, 3 months, 6 months |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Group 2 | Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D. | 0 | 2 | 0 | 2 | 1 | 2 |
| Constipation | Gastrointestinal disorders | Systematic Assessment | Constipation for 5 days |
|
| Kidney Stones | Renal and urinary disorders | Systematic Assessment | right nephrolithiasis |
|
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| D003677 |
| Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| 6-month |
|