Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT)
|ClinicalTrials.gov Identifier: NCT00538720|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2007
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hyperparathyroidism||Drug: Vitamin D Device: Four-dimensional computed tomography (4DCT)||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||October 2007|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|