Effect of Omega-3 Fatty Acids on Oxidative Stress and Dys... | NCT02581449

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

NCT02581449

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Oct 21, 2015Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

End Stage Renal Disease

Interventions

omega-3
empty soft gelatin capsules

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Oct 11, 2015

First Submission Date that Met QC Criteria

Oct 20, 2015

First Posted Date

Oct 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2015

Last Update Posted Date

Oct 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
omega-3 group	Experimental	omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months	Dietary Supplement: omega-3
placebo group	Placebo Comparator	empty soft gelatin capsules with matched size, color and shape once daily for four months	Other: empty soft gelatin capsules

Interventions

Name	Type	Description	Arm Group Labels	Other Names
omega-3	Dietary Supplement	dietary supplement	omega-3 group	NOW foods omega-3 softgels

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ain Shams	university	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004281	Docosahexaenoic Acids

Ancestor Terms

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats

Browse Leaves

Not provided

Browse Branches

Not provided