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NCT00538720 · ClinicalTrials.gov registry record · Phase 1
Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT)
A Phase 1 study of Hyperparathyroidism, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT00538720: Completed Phase 1 study of Hyperparathyroidism, sponsored by M.D. Anderson Cancer Center.
NCT00538720 is a Phase 1 study of Hyperparathyroidism that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 131-participant average among 7 other Hyperparathyroidism trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00538720, a Phase 1 study of Hyperparathyroidism, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
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 PHPT and a Vitamin D deficiency.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Vitamin D
- DEVICE Four-dimensional computed tomography (4DCT)
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2007-10 |
| Est. Completion | 2018-05-30 |
| Phase | Phase 1 |
What the finished NCT00538720 record still lists
NCT00538720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 131-participant average among 7 other Hyperparathyroidism trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Hyperparathyroidism appearing as the primary indexed condition, and to 2 interventions - of which Vitamin D is the first listed.
NCT00538720 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00538720 about?
NCT00538720 is a clinical study titled "Effects of Vitamin D Replacement in Patients With Primary Hyperparathyroidism (PHPT)". 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 PHPT and a Vitamin D deficiency.
What is the current status of trial NCT00538720?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2007-10. Estimated completion is 2018-05-30.
What conditions does trial NCT00538720 study?
This clinical trial studies the following conditions: Hyperparathyroidism.
What interventions are being tested in trial NCT00538720?
The interventions under investigation include: Vitamin D (DRUG), Four-dimensional computed tomography (4DCT) (DEVICE).
Who is sponsoring clinical trial NCT00538720?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00538720 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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