Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01868750
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2013-05-30
Brief Title:
Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia
Sponsor:
David Shonka MD
Organization:
University of Virginia
Study Overview
Official Title:
A Phase 2 Placebo-controlled Randomized Study to Evaluate the Effect of Pre-operative Vitamin D Supplementation on Hypocalcemia Following Total or Near-total Thyroidectomy
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None