Vitamin D Repletion in Primary Hyperparathyroidism

Randomized Controlled Trial of Vitamin D Repletion Regimens 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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism; Vitamin D Deficiency
• Intervention / Treatment: Drug: 10,000 IU Vitamin D3; Dietary supplement: Vitamin D; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Cholecalciferol-D3; Dietary supplement: Vitamin D; Daily multivitamin with 400 IU vitamin D.; Other Names: cholecalciferol
Placebo Comparator: Group 2; Placebo plus a multivitamin with 400 IU vitamin D	Dietary supplement: Vitamin D; Daily multivitamin with 400 IU vitamin D.; Other Names: cholecalciferol; Other: Placebo; Month 1: Placebo once a week Months 2-6: Placebo once a week; Other Names: Placebo pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Parathyroid Hormone (PTH) Level	This is designed to measure how many participants will achieve PTH > 65 pg/mL.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Areal Bone Mineral Density of the Lumbar Spine	Measured by dual-energy x-ray absorptiometry (DEXA) scan	6 months
Trabecular Bone Density at the Forearm	Measured by high resolution peripheral quantitative computed tomography	6 months
Change in Urinary Calcium Level	This is designed to measure how the study treatment will affect urinary calcium level over time.	1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Shonni J Silverberg, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Primary Hyperparathyroidism; Endocrinology; Vitamin D Deficiency; Bone Mineral Density; Metabolic Bone Disease; PHPT; Hyper-calcemia
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Hyperparathyroidism; Hyperparathyroidism, Primary; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: AAAF1797; R01DK084986-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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