Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT)
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00538720
First received: October 2, 2007
Last updated: March 21, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
familial isolated hyperparathyroidism
hyperparathyroidism-jaw tumor syndrome
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 2014 (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:
|
Show Detailed Description 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
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: | March 21, 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 May 22, 2013