Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT)

Completed · Phase 1

Conditions studied: Hyperparathyroidism

In brief

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.

Key facts

Study ID

NCT00538720

Run by

M.D. Anderson Cancer Center

People needed

22

Starts

2007-10-01

Expected to finish

2018-05-30

Last updated by the study team

2019-03-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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