Kidney DiseasesEarly Phase 1NCT00047983
Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients
A Early Phase 1 study testing Canola oil, Arginine and Fish oil emulsion in people with Kidney Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Canola oil, Arginine and Fish oil emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento Apr 2004
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Duke University Medical Center
Durham, North Carolina, 27710
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients
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.
Read the 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.
- Conditions
- Kidney Diseases
- Being tested
- Canola oil, Arginine, Fish oil emulsion
- Keywords
- Kidney Transplantation, Fatty Acids, Omega-3, Erythrocyte Membrane, Graft Survival
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canola oilDietary supplement
ArginineDietary supplement
Fish oil emulsionDietary supplement
Also called Coromega
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Controls and will receive no dietary supplements |
| Arginine and Canola Oil | Experimental | Daily nutritional supplements of arginine and canola oil Receives: Dietary Supplement: Canola oil; Dietary Supplement: Arginine |
| Arginine and Coromega | Experimental | Daily nutritional supplements of arginine and Coromega Receives: Dietary Supplement: Arginine; Dietary Supplement: Fish oil emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increases in omega-3 fatty acid levels in plasma and red blood cell membranes observed in each of the three omega-3 supplements used in this study
Secondary outcomes (1)
Compliance rates observed in each of the three study groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2002 (estimated)
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- J. W. Alexander, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047983
- Sponsor's protocol ID
- DAIT ID01
- Status last verified
- Jan 2017
- First submitted
- 23 Oct 2002
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
van der Heide JJ, Bilo HJ, Donker JM, Wilmink JM, Tegzess AM. Effect of dietary fish oil on renal function and rejection in cyclosporine-treated recipients of renal transplants. N Engl J Med. 1993 Sep 9;329(11):769-73. doi: 10.1056/NEJM199309093291105.
PubMed 8350886Daly JM, Lieberman MD, Goldfine J, Shou J, Weintraub F, Rosato EF, Lavin P. Enteral nutrition with supplemental arginine, RNA, and omega-3 fatty acids in patients after operation: immunologic, metabolic, and clinical outcome. Surgery. 1992 Jul;112(1):56-67.
PubMed 1377838Bower RH, Cerra FB, Bershadsky B, Licari JJ, Hoyt DB, Jensen GL, Van Buren CT, Rothkopf MM, Daly JM, Adelsberg BR. Early enteral administration of a formula (Impact) supplemented with arginine, nucleotides, and fish oil in intensive care unit patients: results of a multicenter, prospective, randomized, clinical trial. Crit Care Med. 1995 Mar;23(3):436-49. doi: 10.1097/00003246-199503000-00006.
PubMed 7874893Alexander JW, Levy A, Custer D, Valente JF, Babcock G, Ogle CK, Schroeder TJ. Arginine, fish oil, and donor-specific transfusions independently improve cardiac allograft survival in rats given subtherapeutic doses of cyclosporin. JPEN J Parenter Enteral Nutr. 1998 May-Jun;22(3):152-5. doi: 10.1177/0148607198022003152.
PubMed 9586793Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
PubMed 39082471
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Immunomodulating Diets With Arginine and Omega-3 Fatty Acids in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00047983
- Acronym / sponsor ID
- DAIT ID01
- Conditions
- Kidney Diseases
- Keywords
- Kidney Transplantation, Fatty Acids, Omega-3, Erythrocyte Membrane, Graft Survival
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Apr 2004 (actual)
- First posted
- 24 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Controls and will receive no dietary supplements |
| Arginine and Canola Oil | Experimental | Dietary Supplement: Canola oil, Dietary Supplement: ArginineDaily nutritional supplements of arginine and canola oil |
| Arginine and Coromega | Experimental | Dietary Supplement: Arginine, Dietary Supplement: Fish oil emulsionDaily nutritional supplements of arginine and Coromega |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canola oil | Dietary supplement | Arginine and Canola Oil |
| Arginine | Dietary supplement | Arginine and Canola Oil, Arginine and Coromega |
| Fish oil emulsionAlso: Coromega | Dietary supplement | Arginine and Coromega |
Primary outcome
Increases in omega-3 fatty acid levels in plasma and red blood cell membranes observed in each of the three omega-3 supplements used in this study
1 secondary outcome
Compliance rates observed in each of the three study groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Background: PubMed 8350886van der Heide JJ, Bilo HJ, Donker JM, Wilmink JM, Tegzess AM. Effect of dietary fish oil on renal function and rejection in cyclosporine-treated recipients of renal transplants. N Engl J Med. 1993 Sep 9;329(11):769-73. doi: 10.1056/NEJM199309093291105.
- Background: PubMed 1377838Daly JM, Lieberman MD, Goldfine J, Shou J, Weintraub F, Rosato EF, Lavin P. Enteral nutrition with supplemental arginine, RNA, and omega-3 fatty acids in patients after operation: immunologic, metabolic, and clinical outcome. Surgery. 1992 Jul;112(1):56-67.
- Background: PubMed 7874893Bower RH, Cerra FB, Bershadsky B, Licari JJ, Hoyt DB, Jensen GL, Van Buren CT, Rothkopf MM, Daly JM, Adelsberg BR. Early enteral administration of a formula (Impact) supplemented with arginine, nucleotides, and fish oil in intensive care unit patients: results of a multicenter, prospective, randomized, clinical trial. Crit Care Med. 1995 Mar;23(3):436-49. doi: 10.1097/00003246-199503000-00006.
- Background: PubMed 9586793Alexander JW, Levy A, Custer D, Valente JF, Babcock G, Ogle CK, Schroeder TJ. Arginine, fish oil, and donor-specific transfusions independently improve cardiac allograft survival in rats given subtherapeutic doses of cyclosporin. JPEN J Parenter Enteral Nutr. 1998 May-Jun;22(3):152-5. doi: 10.1177/0148607198022003152.
- Derived from this study: PubMed 39082471Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. W. Alexander, MD principal investigator
University of Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Canola oil, Arginine and Fish oil emulsion in people with Kidney Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increases in omega-3 fatty acid levels in plasma and red blood cell membranes observed in each of the three omega-3 supplements used in this study. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00047983, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.