Hyperparathyroidism Clinical Trial
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)
Verified date | March 2019 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 30, 2018 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: 1. 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) 2. Be considered an appropriate surgical candidate 3. Be older than 21 years of age 4. Have a vitamin D (25-OHD) level less than or equal to 20ng/ml 5. Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) within two weeks before signing consent Exclusion Criteria: 1. Have any other functional tumors if they have familial multiple endocrine neoplasia syndrome 1 or 2 (MEN 1 or MEN 2) 2. Have a corrected calcium level greater than 13mg/dL 3. Have a recent history of kidney stones 4. Have a recent history of pancreatitis 5. Have a recent history of cardiac arrhythmia (eg atrial fibrillation) 6. Unable to keep still for 2 minutes without coughing 7. Having a body habitus that prevents adequate images to be obtained through the region of the parathyroids (ie typically weighing in excess of 250Lbs) 8. Have a serum creatinine greater than 2.0 mg/dl 9. Have hypersensitivity to ergocalciferol or any component of the formulation |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline to 3-months post treatment |
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