Vitamin D Repletion in Primary Hyperparathyroidism

Completed · Phase 4 · Has a placebo group

Conditions studied: Primary Hyperparathyroidism, Vitamin D Deficiency

In brief

This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.

Key facts

Study ID

NCT01306656

Run by

Columbia University

People needed

9

Starts

2011-10-01

Expected to finish

2017-02-01

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed PHPT, defined by an elevated serum calcium level (we will not study normocalcemic PHPT) with elevated or inappropriately normal PTH levels.
• Vitamin D3 less than 30 ng/ml

You may not qualify if…

• Patients with familial hyperparathyroid syndromes
• Current or past use of the following medications: bisphosphonate within past 2 years, use of lithium or thiazide diuretics, current use of cinacalcet, use of aluminum containing medications, cimetidine, colestipol, or orlistat
• Malignancy, except cured basal or squamous cell skin carcinoma or other cured cancers that are at least five years free from recurrence
• History or current diagnosis of certain medical diseases (including sarcoidosis, active infectious granulomatous disease, HIV/AIDS, chronic kidney disease (serum creatinine > 1.5 mg/dL), liver disease; GI diseases known to affect calcium metabolism; secondary hyperparathyroidism);
• We will also exclude patients with calcium above 11.5 mg/dL, urine calcium above 350 mg/day, and active nephrolithiasis because vitamin D repletion could potentially exacerbate hypercalcemia or hypercalciuria
• Other exclusions include protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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