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

• Status: Completed
• Trial end date: 2018-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

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