Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT) - Full Text View

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

Purpose

Primary hyperparathyroidism (PHPT) is an endocrine disorder that disrupts calcium metabolism. Often coexistent in patients with PHPT is 25-hydroxyvitamin D (25-OHD) deficiency, which can further impact calcium levels. The interaction between these two conditions has not been well-characterized, but use of the new modality of four-dimensional computed tomography (4DCT) may provide some insights.

The primary objective of this pilot study is to obtain preliminary data on the use of 4DCT in patients with concomitant PHPT and 25-OHD deficiency to evaluate the size of parathyroid glands before and after replacement with ergocalciferol (vitamin D2).

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

MedlinePlus related topics: CT Scans

Drug Information available for: Vitamin D Ergocalciferol

U.S. FDA Resources

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)

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

Primary Outcome Measures:

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 PHPT and a Vitamin D deficiency within two weeks prior to signing consent. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	22
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vitamin D	Drug: Vitamin D 50,000 IU PO 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) 4DCT

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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 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 below 20 ng/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 13 mg/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 250 Lbs)
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

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 18, 2008
ClinicalTrials.gov Identifier:	NCT00538720
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Primary Hyperparathyroidism
Vitamin D
Ergocalciferol
PHPT

Study placed in the following topic categories:

Parathyroid Diseases
Vitamin D
Hyperparathyroidism
Hyperparathyroidism, primary

Ergocalciferols
Endocrine System Diseases
Endocrinopathy
Hyperparathyroidism, Primary

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009