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| 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) |
| 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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Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nancy D. Perrier, MD | 713-794-1345 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Nancy D. Perrier, MD | |
| 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 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00538720 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Primary Hyperparathyroidism PHPT Parathyroid glands |
Vitamin D deficiency Vitamin D Ergocalciferol |
|
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 |