Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047983
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2002-10-23
Brief Title:
Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of this study is to evaluate the effectiveness of nutritional supplements in increasing the amount of omega-3 fatty acids and arginine in the red blood cell membranes and plasma of kidney transplant patients and secondarily to compare patient compliance The long-term goal of this study is to develop low risk therapies that will allow improved and lasting survival of donor tissue with minimal suppression of the immune system
Detailed Description:
Short-term survival rates of donor tissue after kidney transplantation have improved significantly in recent years because of improved immunosuppression Rates of long-term tissue loss have changed less because of a high incidence of chronic rejection infectious complications and cardiovascular disease Data suggest that both early and late complications might be reduced in transplant recipients by dietary intervention to raise levels of omega-3 fatty acids and arginine
Prior to transplantation participants are randomized to one of three groups Group 1 participants serve as controls and receive no dietary supplements Participants in Group 2 receive daily nutritional supplements of arginine and canola oil according to body weight Group 3 participants receive daily nutritional supplements of arginine and a fish oil emulsion according to body weight All participants receive a standard low-fat dietary consultation The status of participants is evaluated peri-transplant and at 1 3 6 and 9 months
Prior to transplantation participants are randomized to one of three groups Group 1 participants serve as controls and receive no dietary supplements Participants in Group 2 receive daily nutritional supplements of arginine and canola oil according to body weight Group 3 participants receive daily nutritional supplements of arginine and a fish oil emulsion according to body weight All participants receive a standard low-fat dietary consultation The status of participants is evaluated peri-transplant and at 1 3 6 and 9 months
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