NCT01838239

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

April 18, 2013

Last Update Submit

May 25, 2017

Conditions

Immunoglobulin A NephropathyHealthy Subjects

Keywords

Fish oilOmega-3 fatty acids

Outcome Measures

Primary Outcomes (1)

  • Plasma lipid metabolomic profile

    Plasma lipid metabolomic profile includes fatty acids within lipid classes, oxylipins, lipoprotein particle size and distribution

    Baseline vs. 6 weeks

Secondary Outcomes (1)

  • PBMC gene expression

    Baseline vs. 6 weeks

Other Outcomes (1)

  • Urinary oxylipins

    Baseline vs. 6 weeks

Study Arms (1)

Fish oil

EXPERIMENTAL
Dietary Supplement: Fish Oil

Interventions

Fish OilDIETARY_SUPPLEMENT

Ocean Nutrition Fish Oil Capsules containing 1.9 g eicosapentaenoic acid (EPA) and 1.5 g docosahexaenoic acid (DHA)

Fish oil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Davis, California, 95616, United States

Location

Related Publications (1)

  • 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.

    PMID: 26672987DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Bruce D Hammock, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Angela M Zivkovic, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • J. Bruce German, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 24, 2013

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)