Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis

October 20, 2015 updated by: Areej Mohamed Ateya, Ain Shams University

Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis

The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 8 and 18 years old
  • Patients treated with HD for at least 6 months

Exclusion Criteria:

  • Patients with malignancy and active inflammatory disease.
  • Patients who received vitamin E or any antioxidant treatment during the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: omega-3 group
omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months
Dietary supplement: omega-3
dietary supplement
Other Names:
  • NOW foods omega-3 softgels
Placebo Comparator: placebo group
empty soft gelatin capsules with matched size, color and shape once daily for four months
Other: empty soft gelatin capsules
empty softgels of matched size, shape and color

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde
Time Frame: four months
four months

Secondary Outcome Measures

Outcome Measure
Time Frame
effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)
Time Frame: four months
four months

Other Outcome Measures

Outcome Measure
Time Frame
effect on inflammation via measurement of C- Reactive Protein
Time Frame: four months
four months
effect on nitric oxide (serum concentration)
Time Frame: four months
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ain Shams, University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

October 11, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHCL31528

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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