Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT06154161
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2023-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
Status:
COMPLETED
Status Verified Date:
2025-04
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 6-month prospective interventional clinical trial designed to evaluate the impact of whey protein isolate oral supplement on protein status. Differences in protein status will be evaluated with review of the medical chart from standard of care monthly blood collection for serum albumin, total protein, and normalized protein catabolic rate (nPCR) as detected by serum urea nitrogen. Mid-arm circumference and weight will be measured to ensure no significant changes. Quality of life will be measured to detect if the addition of protein aided in overall quality of life. There will be a 3-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. After the recruitment period has finished, eligible participants will sign the consent form in order to participate in the study. At this point, participants will be provided the supplements for the month and instructed with the amount of water and how to mix with the provided measuring and drinking cup.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: