HyperparathyroidismPhase 1NCT00538720
Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT)
A Phase 1 study testing Vitamin D and Four-dimensional computed tomography (4DCT) in people with Hyperparathyroidism, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn how the standard practice of giving Vitamin D supplements to patients with a Vitamin D deficiency may affect the size of the parathyroid glands in patients with PHPT and a Vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- Vitamin D and Four-dimensional computed tomography (4DCT)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to 30 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed with PHPT (inappropriate PTH level in the setting of a high or high-normal corrected serum calcium level equal to or greater than 10.0 mg/dL)
- Be considered an appropriate surgical candidate
- Be older than 21 years of age
- Have a vitamin D (25-OHD) level less than or equal to 20ng/ml
- Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) within two weeks before signing consent
Who cannot join
- Have any other functional tumors if they have familial multiple endocrine neoplasia syndrome 1 or 2 (MEN 1 or MEN 2)
- Have a corrected calcium level greater than 13mg/dL
- Have a recent history of kidney stones
- Have a recent history of pancreatitis
- Have a recent history of cardiac arrhythmia (eg atrial fibrillation)
- Unable to keep still for 2 minutes without coughing
Show all 9Show fewer
- Having a body habitus that prevents adequate images to be obtained through the region of the parathyroids (ie typically weighing in excess of 250Lbs)
- Have a serum creatinine greater than 2.0 mg/dl
- Have hypersensitivity to ergocalciferol or any component of the formulation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Pilot Study to Detect and Assess the Effect of Vitamin D Replacement on Gland Size by 4DCT in Patients With Primary Hyperparathyroidism (PHPT)
The goal of this clinical research study is to learn how the standard practice of giving Vitamin D supplements to patients with a Vitamin D deficiency may affect the size of the parathyroid glands in patients with PHPT and a Vitamin D deficiency.
Read the detailed description
The Study Vitamin:
In patients with PHPT and a Vitamin D deficiency, Vitamin D supplements are routinely given to bring Vitamin D blood levels up to a normal level before surgery on any abnormal parathyroid glands. When patients have Vitamin D deficiency, they do not absorb calcium very well, so the parathyroid glands have to work harder. This may cause the parathyroid glands to become larger.
Baseline:
If you are found to be eligible to take part in this study, as part of your routine standard of care, you will have a 4-dimensional computed tomography (4DCT) scan of the neck. This 4DCT will be used to find the size and location of your parathyroid glands to help the surgeon in planning the surgery.
Vitamin D Administration:
You will receive Vitamin D pills to take at home, by mouth. You should take the Vitamin D at the same time each day. If it causes an upset stomach, you should take it with food.
You will be given a study diary to record the days that you take the Vitamin D pills. You will return the diary at the end of each cycle.
Cycle 1:
During Cycle 1 (about the first 3 weeks of the study, +/- 1 week), you will take 3 Vitamin D pills per week about every other day (for example, Mondays, Wednesdays, and Fridays).
At the end of Cycle 1, blood (about 1 teaspoon) will be drawn to check Vitamin D levels.
If your Vitamin D level is not high enough at this first Cycle 1 study visit, you will repeat the Cycle 1 dosing schedule a second time. At the end of this second Cycle 1 dosing schedule, you will have another blood test (about 1 teaspoon) to check your Vitamin D levels. If your Vitamin D level is not high enough, you will be taken off study.
If your Vitamin D level is high enough after either your first or second Cycle 1 dosing schedule, you will go to Cycle 2.
Cycle 2:
During Cycle 2, the dosing schedule for Vitamin D is 2 pills per week for 6 weeks (+/- 1 week). You should try to take the pill on the same day of the week.
At the end of Cycle 2, blood (about 1 teaspoon) will be drawn to check Vitamin D levels.
If your Vitamin D level is not high enough at this first Cycle 2 study visit, you will repeat the Cycle 2 dosing schedule a second time. At the end of this second Cycle 2 dosing schedule, you will have another blood test (about 1 teaspoon) to check your Vitamin D levels. If your Vitamin D level is not high enough, you will be taken off study.
If your Vitamin D level is high enough after either your first or second Cycle 2 dosing schedule, you will go to Cycle 3.
Cycle 3:
During Cycle 3, the dosing schedule for Vitamin D is 2 pills per week for 6 weeks (+/- 1 week).
At the end of Cycle 3, blood (about 1 teaspoon) will be drawn to check Vitamin D levels.
If your Vitamin D level is high enough, you will have another 4DCT scan of your neck, for the purpose of this research study. This second scan will be used to see if your parathyroid glands have changed in size. Before this second scan, blood (about 1/2 teaspoon) will be drawn to check your kidney function.
If your Vitamin D level is not high enough, you will be taken off study.
Routine Surgical Treatment:
Within 3 weeks after your second 4DCT scan, your routine surgery for PHPT will be performed. You will sign a separate consent form and its risks will be described in more detail at that time. Your removed parathyroid glands will examined.
Length of Study:
Your active participation in this study will be over after you have surgery. If the side effects of PHPT indicate that you may need to have parathyroid surgery earlier, you will be taken off study early and have the surgery as soon as possible.
This is an investigational study. Vitamin D supplements are commercially available and FDA approved for use in patients with PHPT and a Vitamin D deficiency to bring the Vitamin D blood levels to normal before surgery. It is considered experimental to have a second 4DCT scan after your Vitamin D levels are high enough.
Up to 22 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Hyperparathyroidism
- Being tested
- Vitamin D, Four-dimensional computed tomography (4DCT)
- Keywords
- Primary Hyperparathyroidism, PHPT, Parathyroid glands, Vitamin D deficiency, Vitamin D, Ergocalciferol
- Medical subject headings
- Hyperparathyroidism, Hyperparathyroidism, Primary, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Ergocalciferol
Starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week).
Four-dimensional computed tomography (4DCT)Device
Also called 4DCT, 4-D Computed Tomography
Four-dimensional computed tomography (4DCT) scan of the neck.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Vitamin D starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week). Receives: Drug: Vitamin D; Device: Four-dimensional computed tomography (4DCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of parathyroid glands
Size of individual gland recorded while only the gland with maximum size at baseline included for analysis of primary endpoint. With sample size of 22, a two-sided 95% confidence interval for mean changes in size of parathyroid glands will extend 2.09 from observed mean, assuming that standard deviation is known to be 5 and confidence interval is based on the z statistic. Parameters for parathyroid glands compared pre- and post-replacement on an individual, gland-by-gland basis.
Measured: Baseline to 3-months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startOct 2007
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy D. Perrier, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538720
- Sponsor's protocol ID
- 2007-0425
- Other IDs
- NCI-2012-01591
- Status last verified
- Mar 2019
- First submitted
- 2 Oct 2007
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Detect and Assess the Effect of Vitamin D Replacement on Gland Size by 4DCT in Patients With Primary Hyperparathyroidism (PHPT)
- ClinicalTrials.gov ID
- NCT00538720
- Acronym / sponsor ID
- 2007-0425
- Conditions
- Hyperparathyroidism
- Keywords
- Primary Hyperparathyroidism, PHPT, Parathyroid glands, Vitamin D deficiency, Vitamin D, Ergocalciferol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2007 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn how the standard practice of giving Vitamin D supplements to patients with a Vitamin D deficiency may affect the size of the parathyroid glands in patients with PHPT and a Vitamin D deficiency.
Detailed description
The Study Vitamin:
In patients with PHPT and a Vitamin D deficiency, Vitamin D supplements are routinely given to bring Vitamin D blood levels up to a normal level before surgery on any abnormal parathyroid glands. When patients have Vitamin D deficiency, they do not absorb calcium very well, so the parathyroid glands have to work harder. This may cause the parathyroid glands to become larger.
Baseline:
If you are found to be eligible to take part in this study, as part of your routine standard of care, you will have a 4-dimensional computed tomography (4DCT) scan of the neck. This 4DCT will be used to find the size and location of your parathyroid glands to help the surgeon in planning the surgery.
Vitamin D Administration:
You will receive Vitamin D pills to take at home, by mouth. You should take the Vitamin D at the same time each day. If it causes an upset stomach, you should take it with food.
You will be given a study diary to record the days that you take the Vitamin D pills. You will return the diary at the end of each cycle.
Cycle 1:
During Cycle 1 (about the first 3 weeks of the study, +/- 1 week), you will take 3 Vitamin D pills per week about every other day (for example, Mondays, Wednesdays, and Fridays).
At the end of Cycle 1, blood (about 1 teaspoon) will be drawn to check Vitamin D levels.
If your Vitamin D level is not high enough at this first Cycle 1 study visit, you will repeat the Cycle 1 dosing schedule a second time. At the end of this second Cycle 1 dosing schedule, you will have another blood test (about 1 teaspoon) to check your Vitamin D levels. If your Vitamin D level is not high enough, you will be taken off study.
If your Vitamin D level is high enough after either your first or second Cycle 1 dosing schedule, you will go to Cycle 2.
Cycle 2:
During Cycle 2, the dosing schedule for Vitamin D is 2 pills per week for 6 weeks (+/- 1 week). You should try to take the pill on the same day of the week.
At the end of Cycle 2, blood (about 1 teaspoon) will be drawn to check Vitamin D levels.
If your Vitamin D level is not high enough at this first Cycle 2 study visit, you will repeat the Cycle 2 dosing schedule a second time. At the end of this second Cycle 2 dosing schedule, you will have another blood test (about 1 teaspoon) to check your Vitamin D levels. If your Vitamin D level is not high enough, you will be taken off study.
If your Vitamin D level is high enough after either your first or second Cycle 2 dosing schedule, you will go to Cycle 3.
Cycle 3:
During Cycle 3, the dosing schedule for Vitamin D is 2 pills per week for 6 weeks (+/- 1 week).
At the end of Cycle 3, blood (about 1 teaspoon) will be drawn to check Vitamin D levels.
If your Vitamin D level is high enough, you will have another 4DCT scan of your neck, for the purpose of this research study. This second scan will be used to see if your parathyroid glands have changed in size. Before this second scan, blood (about 1/2 teaspoon) will be drawn to check your kidney function.
If your Vitamin D level is not high enough, you will be taken off study.
Routine Surgical Treatment:
Within 3 weeks after your second 4DCT scan, your routine surgery for PHPT will be performed. You will sign a separate consent form and its risks will be described in more detail at that time. Your removed parathyroid glands will examined.
Length of Study:
Your active participation in this study will be over after you have surgery. If the side effects of PHPT indicate that you may need to have parathyroid surgery earlier, you will be taken off study early and have the surgery as soon as possible.
This is an investigational study. Vitamin D supplements are commercially available and FDA approved for use in patients with PHPT and a Vitamin D deficiency to bring the Vitamin D blood levels to normal before surgery. It is considered experimental to have a second 4DCT scan after your Vitamin D levels are high enough.
Up to 22 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D, Device: Four-dimensional computed tomography (4DCT)Vitamin D starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be diagnosed with PHPT (inappropriate PTH level in the setting of a high or high-normal corrected serum calcium level equal to or greater than 10.0 mg/dL)
- Be considered an appropriate surgical candidate
- Be older than 21 years of age
- Have a vitamin D (25-OHD) level less than or equal to 20ng/ml
- Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) within two weeks before signing consent
Key exclusion criteria (9 listed)
- Have any other functional tumors if they have familial multiple endocrine neoplasia syndrome 1 or 2 (MEN 1 or MEN 2)
- Have a corrected calcium level greater than 13mg/dL
- Have a recent history of kidney stones
- Have a recent history of pancreatitis
- Have a recent history of cardiac arrhythmia (eg atrial fibrillation)
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 |
|---|---|---|
| Vitamin DAlso: ErgocalciferolStarting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week). | Drug | Vitamin D |
| Four-dimensional computed tomography (4DCT)Also: 4DCT, 4-D Computed TomographyFour-dimensional computed tomography (4DCT) scan of the neck. | Device | Vitamin D |
Primary outcome
Size of parathyroid glands
Time frame: Baseline to 3-months post treatment
Size of individual gland recorded while only the gland with maximum size at baseline included for analysis of primary endpoint. With sample size of 22, a two-sided 95% confidence interval for mean changes in size of parathyroid glands will extend 2.09 from observed mean, assuming that standard deviation is known to be 5 and confidence interval is based on the z statistic. Parameters for parathyroid glands compared pre- and post-replacement on an individual, gland-by-gland basis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Nancy D. Perrier, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D and Four-dimensional computed tomography (4DCT) in people with Hyperparathyroidism, run by M.D. Anderson Cancer Center 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 5 inclusion and 9 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 25 Mar 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Size of parathyroid glands (time frame: Baseline to 3-months post treatment). 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 25 Mar 2019.