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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00538720
First received: October 2, 2007
Last updated: September 11, 2013
Last verified: September 2013
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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:


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 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Vitamin D starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week).
Drug: Vitamin D
Starting dose 50,000 IU by mouth 3 times weekly for three weeks (+/- one week), then 50,000 IU twice weekly for 6 weeks (+/- one week).
Other Name: Ergocalciferol
Device: Four-dimensional computed tomography (4DCT)
Four-dimensional computed tomography (4DCT) scan of the neck.
Other Names:
  • 4DCT
  • 4-D Computed Tomography

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. 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)
  2. Be considered an appropriate surgical candidate
  3. Be older than 21 years of age
  4. Have a vitamin D (25-OHD) level less than or equal to 20ng/ml
  5. Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) within two weeks before signing consent

Exclusion Criteria:

  1. Have any other functional tumors if they have familial multiple endocrine neoplasia syndrome 1 or 2 (MEN 1 or MEN 2)
  2. Have a corrected calcium level greater than 13mg/dL
  3. Have a recent history of kidney stones
  4. Have a recent history of pancreatitis
  5. Have a recent history of cardiac arrhythmia (eg atrial fibrillation)
  6. Unable to keep still for 2 minutes without coughing
  7. Having a body habitus that prevents adequate images to be obtained through the region of the parathyroids (ie typically weighing in excess of 250Lbs)
  8. Have a serum creatinine greater than 2.0 mg/dl
  9. Have hypersensitivity to ergocalciferol or any component of the formulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538720

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Nancy D. Perrier, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00538720     History of Changes
Other Study ID Numbers: 2007-0425
Study First Received: October 2, 2007
Last Updated: September 11, 2013
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:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014