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Vitamin D Repletion in Primary Hyperparathyroidism

Phase 4
Completed
Conditions
Primary Hyperparathyroidism
Vitamin D Deficiency
Interventions
Drug: 10,000 IU Vitamin D3
Other: Placebo
Dietary Supplement: Vitamin D
Registration Number
NCT01306656
Lead Sponsor
Columbia University
Brief Summary

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.

Detailed Description

Primary hyperparathyroidism (PHPT) is a common disease in which the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. In primary hyperparathyroidism, high levels of PTH remove too much calcium from bones and deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by the excess calcium loss which weakens the structure of the bones.

Many patients with primary hyperparathyroidism also have low vitamin D (25OHD) levels which is thought to further impair bone health. Recent medical guidelines recommend treating patients with primary hyperparathyroidism who have low vitamin D levels with oral vitamin D but the optimal vitamin D dose and rate of repletion is unclear. It is, therefore, important to determine if replenishing Vitamin D will improve bone health in primary hyperparathyroidism, and if so, to assess the impact of the rate of vitamin D repletion.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
9
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 110,000 IU Vitamin D310,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D
Group 1Vitamin D10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D
Group 2PlaceboPlacebo plus a multivitamin with 400 IU vitamin D
Group 2Vitamin DPlacebo plus a multivitamin with 400 IU vitamin D
Primary Outcome Measures
NameTimeMethod
Serum Parathyroid Hormone (PTH) Level6 months

This is designed to measure how many participants will achieve PTH \> 65 pg/mL.

Secondary Outcome Measures
NameTimeMethod
Areal Bone Mineral Density of the Lumbar Spine6 months

Measured by dual-energy x-ray absorptiometry (DEXA) scan

Trabecular Bone Density at the Forearm6 months

Measured by high resolution peripheral quantitative computed tomography

Change in Urinary Calcium Level1 month, 3 months, 6 months

This is designed to measure how the study treatment will affect urinary calcium level over time.

Trial Locations

Locations (1)

Columbia University Medical Center

🇺🇸

New York, New York, United States

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