Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05084248
Status:
RECRUITING
Last Update Posted:
2023-10-11
First Post:
2021-09-27
Brief Title:
Vitamin D Deficiency in Adults Following a Major Burn Injury
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Vitamin D Deficiency in Adults Following a Major Burn Injury
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This is a single site double blind randomized controlled trial of replacing Vitamin D for Vitamin D-deficient burn patients at a current recommended dose 400 IU daily versus a higher dose 4000 IU daily Capsules will be made in a compounding pharmacy and will look identical
Randomized controlled trial People who meet the selection criteria will be randomized to either low or high dosage of Vitamin D Treatment arm is high dose Vitamin D 4000 IU and control is low dose Vitamin D 400 IU Main outcome variables include PROMIS-29 measures of physical health mental health and social health the Veterans RAND 12 Item Health Survey VR-12 and the 4-D Itch Scale Secondary outcome variables include subject demographics injury demographics and characteristics
Randomized controlled trial People who meet the selection criteria will be randomized to either low or high dosage of Vitamin D Treatment arm is high dose Vitamin D 4000 IU and control is low dose Vitamin D 400 IU Main outcome variables include PROMIS-29 measures of physical health mental health and social health the Veterans RAND 12 Item Health Survey VR-12 and the 4-D Itch Scale Secondary outcome variables include subject demographics injury demographics and characteristics
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None