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Vitamin D Repletion in Primary Hyperparathyroidism

Primary Purpose

Primary Hyperparathyroidism, Vitamin D Deficiency

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

10,000 IU Vitamin D3

Placebo

Vitamin D

About this trial

This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring Endocrinology, Metabolic Bone Disease, Primary Hyperparathyroidism, PHPT, Vitamin D Deficiency, Bone Mineral Density, Hyper-calcemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D

Placebo plus a multivitamin with 400 IU vitamin D

Outcomes

Primary Outcome Measures

Serum Parathyroid Hormone (PTH) Level

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

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

Trabecular Bone Density at the Forearm

Measured by high resolution peripheral quantitative computed tomography

Change in Urinary Calcium Level

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

Full Information

NCT ID

NCT01306656

First Posted

February 10, 2011

Last Updated

March 21, 2019

Sponsor

Columbia University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01306656

Brief Title

Vitamin D Repletion in Primary Hyperparathyroidism

Official Title

Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 2011 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hyperparathyroidism, Vitamin D Deficiency

Keywords

Endocrinology, Metabolic Bone Disease, Primary Hyperparathyroidism, PHPT, Vitamin D Deficiency, Bone Mineral Density, Hyper-calcemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigatorOutcomes Assessor

Masking Description

Patient, investigator and study team will be blinded to study arm ramdomization.

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D

Arm Title

Group 2

Arm Type

Placebo Comparator

Arm Description

Placebo plus a multivitamin with 400 IU vitamin D

Intervention Type

Drug

Intervention Name(s)

10,000 IU Vitamin D3

Other Intervention Name(s)

Cholecalciferol-D3

Intervention Description

Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo pill

Intervention Description

Month 1: Placebo once a week Months 2-6: Placebo once a week

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

cholecalciferol

Intervention Description

Daily multivitamin with 400 IU vitamin D.

Primary Outcome Measure Information:

Title

Serum Parathyroid Hormone (PTH) Level

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Areal Bone Mineral Density of the Lumbar Spine

Description

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

Time Frame

6 months

Title

Trabecular Bone Density at the Forearm

Description

Measured by high resolution peripheral quantitative computed tomography

Time Frame

6 months

Title

Change in Urinary Calcium Level

Description

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

Time Frame

1 month, 3 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shonni J Silverberg, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Vitamin D Repletion in Primary Hyperparathyroidism

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