Primary Hyperparathyroidism (PHPT): Early Effect of Vitamin D

March 4, 2015 updated by: Shonni J. Silverberg, Columbia University

Early Effect of Vitamin D in Primary Hyperparathyroidism

Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people every year. In the presence of this condition, the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by excess calcium loss which weakens bone structure. Other affected organs include the skeleton (calcium loss leads to a "weakening" of the skeleton), and the kidneys (high blood calcium can lead to kidney stones).

It is now evident that the majority of patients with even mild Primary Hyperparathyroidism are vitamin D deficient. In 2009, new international guidelines for the management of asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml). However, no recommendations for vitamin D repletion are given, because of limited data regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore, there is an urgent need for data upon which to base such recommendations, as well as are data on the effects of such treatment upon bones.

Subjects with low vitamin D3 levels will be selected for this trial. They will be given enough vitamin D3 to raise their low blood levels from a low to a normal range. The assessments in this study, including the quadruple label bone biopsy, will allow us to document the short term effects of administering vitamin D3 on changes in bone.

All participants enrolled in this trial will be vitamin D3 deficient. Participants will take an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone changes will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or placebo will be initiated. Six of 7 participants will receive the study drug (active vitamin D3), while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course of tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small piece of bone (about the size of a pencil eraser) will be removed from the hip (iliac crest). The bone will be analyzed to determine the effect of vitamin D3 on primary hyperparathyroidism.

There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy will be performed.

Study Procedures:

Medical and Social History

Blood tests (drawn at the study center and local Quest Lab)

24-Hour urine collection for calcium and creatinine excretion

Abdominal X-ray (to assess for kidney stones)

Transiliac crest Bone Biopsy

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Females and males >= 45 years of age
  2. PHPT, defined as elevated PTH with elevated serum calcium
  3. Screening 25-OHD <= 20 ng/ml

Exclusion Criteria:

  1. Pre-menopausal
  2. Serum calcium is >11.5mg/dl.
  3. Urinary calcium is >350 mg/dl.
  4. Active nephrolithiasis
  5. Nephocalcinosis
  6. Known sensitivity to tetracycline (Sumycin)
  7. Familial history of hyperparathyroid syndromes
  8. Bisphosphonate use within past 2 years.
  9. Current use of Prolia.
  10. Current use of Cinacalcet.
  11. Currently using Cimetidine.
  12. Currently use Colestipol.
  13. Currently using Orlistat.
  14. Current or past malignancy, except cured basal or squamous cell skin carcinoma or other cancers that have not recurred for at least five years.
  15. Current tuberculosis, or history of Sarcoidosis, HIV/AIDS, chronic kidney disease (serum creatinine >= 1.5), liver disease, Crohn's Disease, Celiac Disease, or gastric bypass

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 50,000 IU Vitamin D3
Dietary supplement: Vitamin D3

Baseline:

50,000 IU/week for 8 weeks

Week 8:

Subjects with D3 less than 30 ng/ml: 50,000 IU/week for 4 weeks.

Subjects with D3 25-OHD at or above 30 ng/ml: 50,000 IU/every 2 weeks for 4 weeks.
Placebo Comparator: Placebo (inactive Vitamin D3)
Dietary supplement: Placebo
Subjects will receive placebo vitamin D3, 1 pill weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bone Formation Rate (BFR)
Time Frame: 12 Weeks
A between group (vitamin D3 vs. placebo) comparison of BFR will be performed at three surfaces, cancellous, intra- and endo-cortical.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAF1846
  • R01DK084986 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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