NCT01274910

Brief Summary

This is a single-center, prospective, randomized, double blind, placebo control study. The aim of this study is to assess the effect of fish oil capsules on pain intensity and postoperative analgesics consumption in patients after knee replacement surgery. The study population will be adult are referred for knee replacement surgery due to osteoarthritis of the knee.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 25, 2013

Status Verified

February 1, 2013

Enrollment Period

2.9 years

First QC Date

January 4, 2011

Last Update Submit

November 21, 2013

Conditions

Rheumatoid Arthritis

Keywords

Fish OilKneeAnalgetics

Outcome Measures

Primary Outcomes (2)

  • Pain Levels

    Pain assessment of patients will be measured using visual analog scale (VAS) score.

    10 weeks

  • Analgetics use

    All analgetics drugs used by patient will be noted

    10 weeks

Secondary Outcomes (4)

  • Inflammatory Markers

    Day 1

  • Fatty Acids Composition

    Day 1

  • Cortisol

    Day 1

  • ACTH

    Day 1

Study Arms (2)

Fish oil group

ACTIVE COMPARATOR

Treatment Group.

Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)

Control group

PLACEBO COMPARATOR

Placebo group

Dietary Supplement: Capsules (Placebo)

Interventions

EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)DIETARY_SUPPLEMENT

Patient will receive Fish Oil capsules (EPAX 6000 EE) . Treatment: 5 capsules per day

Also known as: Caps.Omeguard Triomar 1000 mg SGC
Fish oil group
Capsules (Placebo)DIETARY_SUPPLEMENT

Patient will receive capsules which not contain fish oil. Treatment: 5 capsules per day

Control group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are referred for knee replacement surgery due to osteoarthritis of the knee

You may not qualify if:

  • Use of steroids, NSAIDs two weeks before surgery, antidepression drugs, antiepileptic drugs, coumadin
  • Diabetic neuropathy
  • Herpes-zoster/ post-herpetic neuralgia
  • n-3 supplements use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Campus Beilinson

Petah Tikva, Petah Tikva, 49100, Israel

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pierre Singer, Professor, MD

    ICU dep't, Rabin MC,Petah Tikva, Israel

    PRINCIPAL INVESTIGATOR

  • Milana Grinev, RN, Study Coordinator

    ICU dep't, Rabin MC, Petah Tikva, Israel

    STUDY DIRECTOR

Central Study Contacts

Pierre Singer, Professor, MD

CONTACT

972-3-9376521psinger@clalit.org.il

Milana Grinev, RN, Study Coordinator

CONTACT

972-3-9376521milang@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 12, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

November 25, 2013

Record last verified: 2013-02

Locations

IL(1)