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Completed

NCT Number: NCT01306656

Vitamin D Repletion in Primary Hyperparathyroidism

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

10,000 IU Vitamin D3

Drug

Month 1: 20,000 IU vitamin D3 once a week

Months 2-6: 10,000 IU vitamin D3 once a week

Other names: Cholecalciferol-D3

Placebo

Other

Month 1: Placebo once a week

Months 2-6: Placebo once a week

Other names: Placebo pill

Vitamin D

Dietary Supplement

Daily multivitamin with 400 IU vitamin D.

Other names: cholecalciferol

Primary outcomes

  1. Serum Parathyroid Hormone (PTH) Level

    Time frame: 6 months

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

Secondary outcomes

  1. Areal Bone Mineral Density of the Lumbar Spine

    Time frame: 6 months

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

  2. Trabecular Bone Density at the Forearm

    Time frame: 6 months

    Measured by high resolution peripheral quantitative computed tomography

  3. Change in Urinary Calcium Level

    Time frame: 1 month, 3 months, 6 months

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2011
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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