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, 2014
Last verified: September 2014
  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 ]
    Size of individual gland recorded while only the gland with maximum size at baseline included for analysis of primary endpoint. With sample size of 22, a two-sided 95% confidence interval for mean changes in size of parathyroid glands will extend 2.09 from observed mean, assuming that standard deviation is known to be 5 and confidence interval is based on the z statistic. Parameters for parathyroid glands compared pre- and post-replacement on an individual, gland-by-gland basis.


Estimated Enrollment: 22
Study Start Date: October 2007
Estimated Primary Completion Date: October 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
University of Texas 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, NCI-2012-01591
Study First Received: October 2, 2007
Last Updated: September 11, 2014
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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 15, 2014