Vitamin D Repletion in Primary Hyperparathyroidism

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Primary Hyperparathyroidism (PHPT): Early Effect of Vitamin D

NCT01329666

Primary Hyperparathyroidism Hypercalcemia Vitamin D Deficiency +2 more

WITHDRAWN PHASE2/PHASE3

Effect of Vitamin D Treatment in Primary Hyperparathyroidism

NCT00674154

Vitamin D Deficiency Primary Hyperparathyroidism Hypercalcemia

COMPLETED PHASE2/PHASE3

Vitamin D Levels Following Topical Application of Vitamin D Ointment

NCT02676674

Vitamin D Deficiency

COMPLETED PHASE1

Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT)

NCT00538720

Hyperparathyroidism

COMPLETED PHASE1

A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients

NCT01650883

Vitamin D 25 OH Deficiency

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Hyperparathyroidism Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

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

Group Type EXPERIMENTAL

10,000 IU Vitamin D3

Intervention Type DRUG

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

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

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Daily multivitamin with 400 IU vitamin D.

Group 2

Placebo plus a multivitamin with 400 IU vitamin D

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Month 1: Placebo once a week

Months 2-6: Placebo once a week

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Daily multivitamin with 400 IU vitamin D.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Placebo

Month 1: Placebo once a week

Months 2-6: Placebo once a week

Intervention Type OTHER

Vitamin D

Daily multivitamin with 400 IU vitamin D.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cholecalciferol-D3 Placebo pill cholecalciferol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No