Primary HyperparathyroidismPhase 4NCT01306656
Vitamin D Repletion in Primary Hyperparathyroidism
A Phase 4 study testing 10,000 IU Vitamin D3 and Vitamin D in people with Primary Hyperparathyroidism and Vitamin D Deficiency, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism, Vitamin D Deficiency
- What is being tested?
- 10,000 IU Vitamin D3 and Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed PHPT, defined by an elevated serum calcium level (we will not study normocalcemic PHPT) with elevated or inappropriately normal PTH levels.
- Vitamin D3 less than 30 ng/ml
Who cannot join
- Patients with familial hyperparathyroid syndromes
- Current or past use of the following medications: bisphosphonate within past 2 years, use of lithium or thiazide diuretics, current use of cinacalcet, use of aluminum containing medications, cimetidine, colestipol, or orlistat
- Malignancy, except cured basal or squamous cell skin carcinoma or other cured cancers that are at least five years free from recurrence
- History or current diagnosis of certain medical diseases (including sarcoidosis, active infectious granulomatous disease, HIV/AIDS, chronic kidney disease (serum creatinine > 1.5 mg/dL), liver disease; GI diseases known to affect calcium metabolism; secondary hyperparathyroidism);
- We will also exclude patients with calcium above 11.5 mg/dL, urine calcium above 350 mg/day, and active nephrolithiasis because vitamin D repletion could potentially exacerbate hypercalcemia or hypercalciuria
- Other exclusions include protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism
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.
Read the detailed description
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.
- Conditions
- Primary Hyperparathyroidism, Vitamin D Deficiency
- Being tested
- 10,000 IU Vitamin D3, Placebo, Vitamin D
- Keywords
- Endocrinology, Metabolic Bone Disease, Primary Hyperparathyroidism, PHPT, Vitamin D Deficiency, Bone Mineral Density, Hyper-calcemia
- Medical subject headings
- Hyperparathyroidism, Primary, Vitamin D Deficiency, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10,000 IU Vitamin D3Drug
Also called Cholecalciferol-D3
Month 1: 20,000 IU vitamin D3 once a week
Months 2-6: 10,000 IU vitamin D3 once a week
PlaceboOther
Also called Placebo pill
Month 1: Placebo once a week
Months 2-6: Placebo once a week
Vitamin DDietary supplement
Also called cholecalciferol
Daily multivitamin with 400 IU vitamin D.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D Receives: Drug: 10,000 IU Vitamin D3; Dietary Supplement: Vitamin D |
| Group 2 | Placebo comparator | Placebo plus a multivitamin with 400 IU vitamin D Receives: Other: Placebo; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Parathyroid Hormone (PTH) Level
This is designed to measure how many participants will achieve PTH > 65 pg/mL.
Measured: 6 months
Secondary outcomes (3)
Areal Bone Mineral Density of the Lumbar Spine
Measured by dual-energy x-ray absorptiometry (DEXA) scan
Measured: 6 months
Trabecular Bone Density at the Forearm
Measured by high resolution peripheral quantitative computed tomography
Measured: 6 months
Change in Urinary Calcium Level
This is designed to measure how the study treatment will affect urinary calcium level over time.
Measured: 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shonni J. Silverberg, Columbia University
- Investigators
- Shonni J Silverberg, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306656
- Sponsor's protocol ID
- AAAF1797
- Other IDs
- R01DK084986-05
- Status last verified
- Mar 2019
- First submitted
- 10 Feb 2011
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT01306656
- Acronym / sponsor ID
- AAAF1797
- Conditions
- Primary Hyperparathyroidism, Vitamin D Deficiency
- Keywords
- Endocrinology, Metabolic Bone Disease, Primary Hyperparathyroidism, PHPT, Vitamin D Deficiency, Bone Mineral Density, Hyper-calcemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2011 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: 10,000 IU Vitamin D3, Dietary Supplement: Vitamin D10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D |
| Group 2 | Placebo comparator | Other: Placebo, Dietary Supplement: Vitamin DPlacebo plus a multivitamin with 400 IU vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed PHPT, defined by an elevated serum calcium level (we will not study normocalcemic PHPT) with elevated or inappropriately normal PTH levels.
- Vitamin D3 less than 30 ng/ml
Key exclusion criteria (6 listed)
- Patients with familial hyperparathyroid syndromes
- Current or past use of the following medications: bisphosphonate within past 2 years, use of lithium or thiazide diuretics, current use of cinacalcet, use of aluminum containing medications, cimetidine, colestipol, or orlistat
- Malignancy, except cured basal or squamous cell skin carcinoma or other cured cancers that are at least five years free from recurrence
- History or current diagnosis of certain medical diseases (including sarcoidosis, active infectious granulomatous disease, HIV/AIDS, chronic kidney disease (serum creatinine > 1.5 mg/dL), liver disease; GI diseases known to affect calcium metabolism; secondary hyperparathyroidism);
- We will also exclude patients with calcium above 11.5 mg/dL, urine calcium above 350 mg/day, and active nephrolithiasis because vitamin D repletion could potentially exacerbate hypercalcemia or hypercalciuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10,000 IU Vitamin D3Also: Cholecalciferol-D3Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week | Drug | Group 1 |
| PlaceboAlso: Placebo pillMonth 1: Placebo once a week Months 2-6: Placebo once a week | Other | Group 2 |
| Vitamin DAlso: cholecalciferolDaily multivitamin with 400 IU vitamin D. | Dietary supplement | Group 1, Group 2 |
Primary outcome
Serum Parathyroid Hormone (PTH) Level
Time frame: 6 months
This is designed to measure how many participants will achieve PTH > 65 pg/mL.
3 secondary outcomes
Areal Bone Mineral Density of the Lumbar Spine
Time frame: 6 months
Trabecular Bone Density at the Forearm
Time frame: 6 months
Change in Urinary Calcium Level
Time frame: 1 month, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shonni J Silverberg, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10,000 IU Vitamin D3 and Vitamin D in people with Primary Hyperparathyroidism and Vitamin D Deficiency, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Parathyroid Hormone (PTH) Level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.