Immunoglobulin A NephropathyNCT01838239
Development of a Metabolic Assessment Tool for Chronic Kidney Disease
A study testing Fish Oil in people with Immunoglobulin A Nephropathy and Healthy Subjects, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to examine the variation between individuals in blood lipid metabolites, and the changes in these metabolites in response to omega-3 fatty acids in patients with immunoglobulin A nephropathy (IgAN) and in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunoglobulin A Nephropathy, Healthy Subjects
- What is being tested?
- Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2011
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight at least 110 pounds or BMI at least 19
- Adult (aged 18-65 years old)
- Disclose which medications currently taking
- Able to come to the Ragle Center at the designated times
- Able to give blood
- Able to take 6 g fish oil per day for 6 weeks
Show all 9Show fewer
- Able to carry out first morning urine collection
- Able to stop or avoid taking NSAIDS and allergy medications for 6 weeks
- Able to stop or avoid eating seafood and seaweed for 6 weeks
Who cannot join
- Pregnant or nursing (or unsure if pregnant)
- Diagnosed with a disease by their physician
- Currently taking prescription medications that alter lipid metabolism (such as HMG CoA reductase inhibitors, PPAR agonists, steroids) and/or anti-coagulants
- Currently has some form of anemia (or unsure)
- Has an existing health condition or concern
- Unable to stop or avoid taking NSAIDS and allergy medications for 6 weeks
Show all 9Show fewer
- Unable to stop or avoid eating seafood or seaweed for 6 weeks
- Unable to give blood or do first morning urine collection
- Recently recovering from a major injury, infection, or illness (in the last 2-4 weeks)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Davis, California, 95616
About this study
The purpose of this study is to examine the variation between individuals in blood lipid metabolites, and the changes in these metabolites in response to omega-3 fatty acids in patients with immunoglobulin A nephropathy (IgAN) and in healthy subjects. The hypothesis is that measuring variation among individuals and changes in response to omega-3 fatty acids comprehensively by using metabolomics will help to identify those individuals who are responders and those who are non-responders to omega-3 fatty acids as an anti-inflammatory intervention.
Read the detailed description
It is unclear how metabolomic profiles of individuals change in response to short-term intervention with omega-3 fatty acids. It is necessary to establish the means and standard deviations in the levels of omega-3 fatty acids and their related metabolites in healthy subjects and in different disease states in order to better understand the mechanisms related to lipid metabolism of metabolic diseases that are modified by omega-3 fatty acids. Specifically, the project will examine the metabolomic profiles of healthy controls and patients with immunoglobulin A nephropathy (IgAN) before and after an omega-3 fatty acid intervention. The IgAN patient samples were obtained from collaborators from a previously completed project. The healthy subjects were tested in a small pilot trial conducted at UC Davis as described below.
- Twelve healthy volunteers willing and able to take 6 g of fish oil for 6 weeks were recruited from the general UC Davis population including students, faculty, and staff. The volunteers were recruited by personal communication at seminars and other school-related activities as well as flyers posted on campus.
- The volunteers were contacted and scheduled for a screening and consent visit. Subjects who met all eligibility criteria and signed a consent form were then scheduled for a baseline blood draw and to collect a first morning urine sample. A research team member contacted each subject the day before their first scheduled study date to confirm and remind the subject about fasting, about collecting the first morning urine void, and the time and location of the study.
- On each study visit, the participants came to the Ragle Human Nutrition Center (1283 Academic Surge) between 7 and 9 am after an overnight fast, at which point they were weighed (clothed but with no shoes) on a digital scale and their height was measured. A registered phlebotomist drew 20 mL of blood by venipuncture for their baseline blood draw. Subjects also brought in their first morning urine sample at this time. Subjects were then given their fish oil capsules that were separated in a Ziploc bag for each week of the intervention. Subjects took the fish oil capsules at home at their own discretion but study personnel suggested they take the capsules after their last meal of the day and before bed each evening. Study personnel contacted subjects throughout the course of the study by phone and/or e-mail to make sure that there were no adverse effects from the fish oil and to ensure compliance. Subjects were instructed to record their diets through 24-hour dietary recalls before the baseline blood draw, and at 3 additional time points throughout the study.
- Immediately after blood collection, the researchers separated the red blood cells and peripheral blood mononuclear cells (PBMC) from the plasma, aliquoted the samples, and then stored them in a -70°C freezer for future analysis.
- Conditions
- Immunoglobulin A Nephropathy, Healthy Subjects
- Being tested
- Fish Oil
- Keywords
- Fish oil, Omega-3 fatty acids
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Ocean Nutrition Fish Oil Capsules containing 1.9 g eicosapentaenoic acid (EPA) and 1.5 g docosahexaenoic acid (DHA)
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | Not described Receives: Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipid metabolomic profile
Plasma lipid metabolomic profile includes fatty acids within lipid classes, oxylipins, lipoprotein particle size and distribution
Measured: Baseline vs. 6 weeks
Secondary outcomes (1)
PBMC gene expression
Measurement of changes in gene expression in peripheral blood mononuclear cells
Measured: Baseline vs. 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2011
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 Immunoglobulin A NephropathyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce D Hammock, PhD, Principal investigator, University of California, DavisAngela M Zivkovic, PhD, Principal investigator, University of California, DavisJ. Bruce German, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838239
- Sponsor's protocol ID
- 200715313
- Status last verified
- May 2017
- First submitted
- 18 Apr 2013
- Last updated
- 30 May 2017
- Results posted
- No
Publications
Berthelot CC, Kamita SG, Sacchi R, Yang J, Nording ML, Georgi K, Hegedus Karbowski C, German JB, Weiss RH, Hogg RJ, Hammock BD, Zivkovic AM. Changes in PTGS1 and ALOX12 Gene Expression in Peripheral Blood Mononuclear Cells Are Associated with Changes in Arachidonic Acid, Oxylipins, and Oxylipin/Fatty Acid Ratios in Response to Omega-3 Fatty Acid Supplementation. PLoS One. 2015 Dec 16;10(12):e0144996. doi: 10.1371/journal.pone.0144996. eCollection 2015.
PubMed 26672987
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Metabolic Assessment Tool for Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01838239
- Acronym / sponsor ID
- 200715313
- Conditions
- Immunoglobulin A Nephropathy, Healthy Subjects
- Keywords
- Fish oil, Omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Apr 2013 (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 examine the variation between individuals in blood lipid metabolites, and the changes in these metabolites in response to omega-3 fatty acids in patients with immunoglobulin A nephropathy (IgAN) and in healthy subjects. The hypothesis is that measuring variation among individuals and changes in response to omega-3 fatty acids comprehensively by using metabolomics will help to identify those individuals who are responders and those who are non-responders to omega-3 fatty acids as an anti-inflammatory intervention.
Detailed description
It is unclear how metabolomic profiles of individuals change in response to short-term intervention with omega-3 fatty acids. It is necessary to establish the means and standard deviations in the levels of omega-3 fatty acids and their related metabolites in healthy subjects and in different disease states in order to better understand the mechanisms related to lipid metabolism of metabolic diseases that are modified by omega-3 fatty acids. Specifically, the project will examine the metabolomic profiles of healthy controls and patients with immunoglobulin A nephropathy (IgAN) before and after an omega-3 fatty acid intervention. The IgAN patient samples were obtained from collaborators from a previously completed project. The healthy subjects were tested in a small pilot trial conducted at UC Davis as described below.
- Twelve healthy volunteers willing and able to take 6 g of fish oil for 6 weeks were recruited from the general UC Davis population including students, faculty, and staff. The volunteers were recruited by personal communication at seminars and other school-related activities as well as flyers posted on campus.
- The volunteers were contacted and scheduled for a screening and consent visit. Subjects who met all eligibility criteria and signed a consent form were then scheduled for a baseline blood draw and to collect a first morning urine sample. A research team member contacted each subject the day before their first scheduled study date to confirm and remind the subject about fasting, about collecting the first morning urine void, and the time and location of the study.
- On each study visit, the participants came to the Ragle Human Nutrition Center (1283 Academic Surge) between 7 and 9 am after an overnight fast, at which point they were weighed (clothed but with no shoes) on a digital scale and their height was measured. A registered phlebotomist drew 20 mL of blood by venipuncture for their baseline blood draw. Subjects also brought in their first morning urine sample at this time. Subjects were then given their fish oil capsules that were separated in a Ziploc bag for each week of the intervention. Subjects took the fish oil capsules at home at their own discretion but study personnel suggested they take the capsules after their last meal of the day and before bed each evening. Study personnel contacted subjects throughout the course of the study by phone and/or e-mail to make sure that there were no adverse effects from the fish oil and to ensure compliance. Subjects were instructed to record their diets through 24-hour dietary recalls before the baseline blood draw, and at 3 additional time points throughout the study.
- Immediately after blood collection, the researchers separated the red blood cells and peripheral blood mononuclear cells (PBMC) from the plasma, aliquoted the samples, and then stored them in a -70°C freezer for future analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Experimental | Dietary Supplement: Fish Oil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Weight at least 110 pounds or BMI at least 19
- Adult (aged 18-65 years old)
- Disclose which medications currently taking
- Able to come to the Ragle Center at the designated times
- Able to give blood
Key exclusion criteria (9 listed)
- Pregnant or nursing (or unsure if pregnant)
- Diagnosed with a disease by their physician
- Currently taking prescription medications that alter lipid metabolism (such as HMG CoA reductase inhibitors, PPAR agonists, steroids) and/or anti-coagulants
- Currently has some form of anemia (or unsure)
- Has an existing health condition or concern
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 |
|---|---|---|
| Fish OilOcean Nutrition Fish Oil Capsules containing 1.9 g eicosapentaenoic acid (EPA) and 1.5 g docosahexaenoic acid (DHA) | Dietary supplement | Fish oil |
Primary outcome
Plasma lipid metabolomic profile
Time frame: Baseline vs. 6 weeks
Plasma lipid metabolomic profile includes fatty acids within lipid classes, oxylipins, lipoprotein particle size and distribution
1 secondary outcome
PBMC gene expression
Time frame: Baseline vs. 6 weeks
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 30 May 2017.
- Derived from this study: PubMed 26672987Berthelot CC, Kamita SG, Sacchi R, Yang J, Nording ML, Georgi K, Hegedus Karbowski C, German JB, Weiss RH, Hogg RJ, Hammock BD, Zivkovic AM. Changes in PTGS1 and ALOX12 Gene Expression in Peripheral Blood Mononuclear Cells Are Associated with Changes in Arachidonic Acid, Oxylipins, and Oxylipin/Fatty Acid Ratios in Response to Omega-3 Fatty Acid Supplementation. PLoS One. 2015 Dec 16;10(12):e0144996. doi: 10.1371/journal.pone.0144996. eCollection 2015.
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RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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RecruitingPhase 3
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Kidney Disease
Not yet recruiting
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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.
Bruce D Hammock, PhD principal investigator
University of California, Davis
Angela M Zivkovic, PhD principal investigator
University of California, Davis
J. Bruce German, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil in people with Immunoglobulin A Nephropathy and Healthy Subjects, run by University of California, Davis at 1 site 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 9 inclusion and 9 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 lipid metabolomic profile (time frame: Baseline vs. 6 weeks). 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 NCT01838239, 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 30 May 2017.