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Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients Clinical research trials and Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients. Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients clinical trial. Human subjects frequently get the finest healthcare available for their Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients  Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients
Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients
For Condition: Kidney Diseases
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 4 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - End-stage renal disease. - Candidate to receive a living-related donor, living unrelated donor, or first cadaver kidney with at least 1 HLA mismatch. - Negative crossmatch with the intended donor. - Adults must have moderate to severe hypertension and/or take at least 1 medication for hypertension daily. - Willingness to comply with the dietary supplements, including canola oil, a flavored drink mix, or an orange flavored pudding. Exclusion Criteria: - Pregnancy or breast-feeding. - Women of childbearing age who are not willing or able to practice acceptable methods of contraception. - HIV-positive. - Positive test for HBV E-AG/DNA and HCV. - Received an organ transplant or plan to receive a multiple organ transplant. - Phenylketonuria. - Participation in other investigational studies within 30 days of the renal transplant. - Allergy or anaphylactic reactions to eggs or L-arginine. - ABO blood incompatibility. - Children who have previously received more than 5 blood transfusions. - History of stroke.
Total Enrollment: 75
Location and Contact Information:
Overall Study Official:
J.Alexander, Principal Investigator, Univerisy of Cincinnati College of Medicine
Univerisity of Cincinnati College of Medicine *Recruiting*
Cincinnati, Ohio, 45267
United States
Recruiting Wesley Alexander 513-558-6006
Washington Hospital Center *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting Jimmy Light 202-877-6029
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Paul Kuo 919-668-1856
University of Maryland School of Medicine *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Clarence Foster 410-328-5408
Additional Information:
Study ID Numbers: DAIT ID01;
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047983
Other Kidney Diseases Studies:
1. Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
2. A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients with Methotrexate Toxicity and Renal Dysfunction
3. Dynamic Aspects of Amino Acid Metabolism
4. Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients
5. Look AHEAD: Action for Health in Diabetes
Related Studies:
Other Kidney Diseases Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients
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