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

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, September 2009

First Received: October 2, 2007 Last Updated: September 4, 2009 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00538720

Purpose

The goal of this clinical research study is to learn how the standard practice of giving Vitamin D supplements to patients with a Vitamin D deficiency may affect the size of the parathyroid glands in patients with Primary hyperparathyroidism (PHPT) and a Vitamin D deficiency within two weeks prior to signing consent.

Condition	Intervention	Phase
Hyperparathyroidism	Drug: Vitamin D Device: Four-dimensional computed tomography (4DCT)	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study to Detect and Assess the Effect of Vitamin D Replacement on Gland Size by 4DCT in Patients With Primary Hyperparathyroidism (PHPT)

Resource links provided by NLM:

MedlinePlus related topics: CT Scans

Drug Information available for: Ergocalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Size of parathyroid glands [ Time Frame: Baseline to 3-months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	22
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vitamin D: Experimental	Drug: Vitamin D Starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU once weekly for 6 weeks (+/- one week). Device: Four-dimensional computed tomography (4DCT) Four-dimensional computed tomography (4DCT) scan of the neck.

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Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Be diagnosed with PHPT (inappropriate PTH level in the setting of a high or high-normal corrected serum calcium level equal to or greater than 10.0 mg/dL)
Be considered an appropriate surgical candidate
Be older than 21 years of age
Have a vitamin D (25-OHD) level less than or equal to 20ng/ml
Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) within two weeks before signing consent

Exclusion Criteria:

Have any other functional tumors if they have familial multiple endocrine neoplasia syndrome 1 or 2 (MEN 1 or MEN 2)
Have a corrected calcium level greater than 13mg/dL
Have a recent history of kidney stones
Have a recent history of pancreatitis
Have a recent history of cardiac arrhythmia (eg atrial fibrillation)
Unable to keep still for 2 minutes without coughing
Having a body habitus that prevents adequate images to be obtained through the region of the parathyroids (ie typically weighing in excess of 250Lbs)
Have a serum creatinine greater than 2.0 mg/dl
Have hypersensitivity to ergocalciferol or any component of the formulation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538720

Contacts

Contact: Nancy D. Perrier, MD

713-794-1345

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Nancy D. Perrier, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Nancy D. Perrier, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Nancy D. Perrier, MD/Associate Professor )
Study ID Numbers:	2007-0425
Study First Received:	October 2, 2007
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00538720 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Primary Hyperparathyroidism
PHPT
Parathyroid glands

Vitamin D deficiency
Vitamin D
Ergocalciferol

Additional relevant MeSH terms:

Parathyroid Diseases
Vitamin D
Hyperparathyroidism
Growth Substances
Vitamins
Physiological Effects of Drugs

Ergocalciferols
Endocrine System Diseases
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions
Hyperparathyroidism, Primary

ClinicalTrials.gov processed this record on February 08, 2010