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NCT01868750 · ClinicalTrials.gov registry record · Phase 2
Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia
A Phase 2 study of Thyroid Nodules and Hypocalcemia, sponsored by David Shonka, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT01868750 is a Phase 2 study of Thyroid Nodules and Hypocalcemia that has completed, run by David Shonka, MD. The registered enrollment target is 67 participants, below the 161-participant average among 3 other Thyroid Nodules trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01868750, a Phase 2 study of Thyroid Nodules and Hypocalcemia, has completed, sponsored by David Shonka, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities. Severe symptoms are life threatening, so it is important to start the management of these symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a few extra days in the hospital. The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the calcium needed to make strong bones and teeth. The purpose of this study is to determine if taking vitamin D before surgery to remove the thyroid gland affects whether or not you may have low calcium levels after your surgery and to test the hypothesis that those who are given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital stay.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Calcitriol
- DIETARY_SUPPLEMENT Control Pill
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2013-05 |
| Est. Completion | 2021-07-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01868750
The ClinicalTrials.gov registry entry for NCT01868750 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 161-participant average among 3 other Thyroid Nodules trials with a reported enrollment target (58% lower). The listed sponsor is David Shonka, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Thyroid Nodules appearing as the primary indexed condition, and to 2 interventions - of which Calcitriol is the first listed.
NCT01868750 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT01868750 about?
NCT01868750 is a clinical study titled "Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia". One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, ...
What is the current status of trial NCT01868750?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2013-05. Estimated completion is 2021-07-08.
What conditions does trial NCT01868750 study?
This clinical trial studies the following conditions: Thyroid Nodules, Hypocalcemia.
What interventions are being tested in trial NCT01868750?
The interventions under investigation include: Calcitriol (DIETARY_SUPPLEMENT), Control Pill (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01868750?
This trial is sponsored by David Shonka, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01868750 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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