Chronic Renal DiseaseNCT00560014
Nutrient Levels Alter Transplant Outcome
A study testing Arginine and canola oil and Coromega and Arginine in people with Chronic Renal Disease, run by University of Cincinnati at 2 sites in United States.
Trial summary
The purpose of this study is to look at lipid profiles of plasma and RBC and amino acid profiles in plasma to determine if they are associated with allograft rejection, calcineurin inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving dietary supplements with arginine and omega-3… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- Arginine and canola oil and Coromega and Arginine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1997to May 2005
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Renal transplant recipient
- Appropriate blood samples drawn and analyzed
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University School Of Medicine
Durham, North Carolina, 27710
Washington Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Role of Immunonutrient Levels in Preventing Complications After Renal Transplantation
The purpose of this study is to look at lipid profiles of plasma and RBC and amino acid profiles in plasma to determine if they are associated with allograft rejection, calcineurin inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving dietary supplements with arginine and omega-3 fatty acids.
- Conditions
- Chronic Renal Disease
- Being tested
- Arginine and canola oil, Coromega and Arginine
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine and canola oilDietary supplement
Also called Arginaid
Canola oil 1 tablespoon BID Arginine 9.0grams BID
Coromega and ArginineDietary supplement
Also called Arginaide
Arginine 9.0 grams BID Coromega dose based on weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arginine and Canola oil supplemented group Receives: Dietary Supplement: Arginine and canola oil |
| 2 | Experimental | Arginine and Coromega Receives: Dietary Supplement: Coromega and Arginine |
| 3 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and red blood cell lipid profiles
Measured: Within 1 year
Plasma amino acid profiles
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startSep 1997
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- J. W. Alexander, M.D., Principal investigator, UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560014
- Sponsor's protocol ID
- LIPIDS
- Other IDs
- R03 AI142743, 5U01AI040167
- Status last verified
- Oct 2007
- First submitted
- 14 Nov 2007
- Last updated
- 19 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexander JW, Goodman HR, Succop P, Light JA, Kuo PC, Moser AB, James JH, Woodle ES. Influence of long chain polyunsaturated fatty acids and ornithine concentrations on complications after renal transplant. Exp Clin Transplant. 2008 Jun;6(2):118-26.
PubMed 18816238
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Immunonutrient Levels in Preventing Complications After Renal Transplantation
- ClinicalTrials.gov ID
- NCT00560014
- Acronym / sponsor ID
- LIPIDS
- Conditions
- Chronic Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 1997
- Study completion
- May 2005 (actual)
- First posted
- 19 Nov 2007 (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 look at lipid profiles of plasma and RBC and amino acid profiles in plasma to determine if they are associated with allograft rejection, calcineurin inhibitor toxicity or new onset diabetes mellitus in renal transplant patients receiving dietary supplements with arginine and omega-3 fatty acids.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Arginine and canola oilArginine and Canola oil supplemented group |
| 2 | Experimental | Dietary Supplement: Coromega and ArginineArginine and Coromega |
| 3 | No intervention | –Control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Renal transplant recipient
- Appropriate blood samples drawn and analyzed
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Arginine and canola oilAlso: ArginaidCanola oil 1 tablespoon BID Arginine 9.0grams BID | Dietary supplement | 1 |
| Coromega and ArginineAlso: ArginaideArginine 9.0 grams BID Coromega dose based on weight | Dietary supplement | 2 |
Primary outcome
Plasma and red blood cell lipid profiles
Time frame: Within 1 year
Plasma amino acid profiles
Time frame: within 1 year
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 19 Nov 2007.
- Derived from this study: PubMed 18816238Alexander JW, Goodman HR, Succop P, Light JA, Kuo PC, Moser AB, James JH, Woodle ES. Influence of long chain polyunsaturated fatty acids and ornithine concentrations on complications after renal transplant. Exp Clin Transplant. 2008 Jun;6(2):118-26.
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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, M.D. principal investigator
UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine and canola oil and Coromega and Arginine in people with Chronic Renal Disease, run by University of Cincinnati at 2 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 2 inclusion and 0 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 19 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Plasma and red blood cell lipid profiles (time frame: Within 1 year). The study lists 2 primary outcomes in all. 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 NCT00560014, which also lists 1 linked publication.
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 19 Nov 2007.