Effects of Vitamin D Replacement 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 Primary hyperparathyroidism (PHPT) and a Vitamin D deficiency within two weeks prior to signing consent.
Drug: Vitamin D
Device: Four-dimensional computed tomography (4DCT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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)|
- Size of parathyroid glands [ Time Frame: Baseline to 3-months post treatment ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2007|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D
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).
Drug: 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).
Other Name: ErgocalciferolDevice: Four-dimensional computed tomography (4DCT)
Four-dimensional computed tomography (4DCT) scan of the neck.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00538720
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nancy D. Perrier, MD||M.D. Anderson Cancer Center|