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Vitamin D Repletion in Primary Hyperparathyroidism

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Shonni J. Silverberg, Columbia University
ClinicalTrials.gov Identifier:
NCT01306656
First received: February 10, 2011
Last updated: May 17, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Primary Hyperparathyroidism Vitamin D Deficiency Drug: 10,000 IU Vitamin D3 Other: Placebo Dietary Supplement: Vitamin D Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Active arm:

Month 1: 20,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D.

Months 2-6: 10,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D.

Placebo arm:

Month 1: Placebo once a week plus daily multivitamin with 400 IU vitamin D.

Months 2-6: Placebo every week plus daily multivitamin with 400 IU vitamin D.

Masking: Participant, Investigator, Outcomes Assessor
Masking Description:
Patient, investigator and study team will be blinded to study arm ramdomization.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Shonni J. Silverberg, Columbia University:

Primary Outcome Measures:
  • Serum parathyroid hormone (PTH) level [ Time Frame: 6 months ]
    This is designed to measure how many participants will achieve PTH > 65 pg/mL.


Secondary Outcome Measures:
  • Areal bone mineral density of the lumbar spine [ Time Frame: 6 months ]
    Measured by DXA

  • Trabecular bone density at the forearm [ Time Frame: 6 months ]
    Measured by high resolution peripheral quantitative computed tomography

  • 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.


Enrollment: 10
Actual Study Start Date: October 2011
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D
Drug: 10,000 IU Vitamin D3

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

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

Other Name: Cholecalciferol-D3
Dietary Supplement: Vitamin D
Daily multivitamin with 400 IU vitamin D.
Other Name: cholecalciferol
Placebo Comparator: Group 2
Placebo plus a multivitamin with 400 IU vitamin D
Other: Placebo

Month 1: Placebo once a week

Months 2-6: Placebo once a week

Other Name: Placebo pill
Dietary Supplement: Vitamin D
Daily multivitamin with 400 IU vitamin D.
Other Name: cholecalciferol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306656

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Shonni J Silverberg, MD Columbia University
  More Information

Responsible Party: Shonni J. Silverberg, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01306656     History of Changes
Other Study ID Numbers: AAAF1797
R01DK084986-05 ( U.S. NIH Grant/Contract )
Study First Received: February 10, 2011
Last Updated: May 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Shonni J. Silverberg, Columbia University:
Endocrinology
Metabolic Bone Disease
Primary Hyperparathyroidism
PHPT
Vitamin D Deficiency
Bone Mineral Density
Hyper-calcemia

Additional relevant MeSH terms:
Hyperparathyroidism, Primary
Hyperparathyroidism
Vitamin D Deficiency
Parathyroid Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 21, 2017