Effect of Omega 3 Fatty Acids on the Vascular Calcificati... | NCT03982966

Studies
Effect of Omega 3 Fatty Acids on the Vascular Calcification Biomarkers Fetuin A and Osteoprotegerin in Patients With CRF

NCT03982966

Sponsor

Damanhour University

Status

Completed

Last Update Posted

Jun 25, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Chronic Renal Failure

Interventions

Omega 3 fatty acids (fish oil) 1000 mg/day oral

Countries

Egypt

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

May 1, 2020Actual

First Submitted Date

Jun 9, 2019

First Submission Date that Met QC Criteria

Jun 9, 2019

First Posted Date

Jun 12, 2019Actual

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

Jun 24, 2020

Last Update Posted Date

Jun 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rehab Werida, Clinical Pharmacy Lecturer, Damanhour UniversityPrincipal Investigator

Lead Sponsor

Damanhour UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

study the effect of omega 3fatty acids on the vascular calcification biomarkers Fetuin -A and Osteoprotegerin (OPG) in dialysis patients.

Detailed Description

2-All Participants agreed to take part in this clinical research and provide informed consent.

3-Patients undergo both undergo hemodialysis (HD) will be enrolled from dialysis unit in al Moussa Hospital Alexandria.

4-Serum samples will be collected for measuring the biomarkers. 5-Our design is randomized, controlled, open-intervention study. 6- All enrolled patients will be divided into 2 groups, Group 1 will be 40 patients that will take omega 3fatty acids and Group 2 will be 20 patients will not take omega 3 fatty acids.

7-All patients will be followed up during 6 months' period. 8-Statsicial tests appropriate to the study design will be conducted to evaluate the significance of the results.

9-Measuring outcome: the primary outcome is the increase of the serum levels of the vascular calcification biomarkers after 6months.

10-Results, conclusions, discussion and recommendations will be given.

Inclusion criteria:

60 hemodialysis patients, (20-80) years old.
Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at least 6months).

Exclusion Criteria:

People with active infections (fever or any evidence of infections), known malignancy, connective tissue disorders, immunosuppressive therapy, and inflammatory diseases, current use of warfarin ,history of fish oil/omega 3 allergies were excluded.

Methodology:

Feutin-A and Osteoprotegrin (OPG) will be determined by ELISA.
Serum lipid levels, phosphorus, calcium, Parathormone (i-PTH), alkaline phosphatase, albumin and creatine levels.
BMI

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omega 3	Experimental	Group 1 will be 40 patients that will take Omega 3 fatty acids (fish oil)	Dietary Supplement: Omega 3 fatty acids (fish oil) 1000 mg/day oral
Control	No Intervention	20 patients will not take omega 3 fatty acids.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega 3 fatty acids (fish oil) 1000 mg/day oral	Dietary Supplement	Omega 3 fatty acids (fish oil) 1000 mg/day oral	Omega 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feutin-A Level	vascular calcification biomarkers	six months
Osteoprotegrin	vascular calcification biomarkers	six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

60 hemodialysis patients, (20-80) years old.
Enrolled HD patients received regular HD 3 times weekly (on chronic maintenance for at least 6 months).

Exclusion Criteria:

People with active infections (fever or any evidence of infections), known malignancy, connective tissue disorders, immunosuppressive therapy, and inflammatory diseases, current use of warfarin ,history of fish oil/omega 3 allergies were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rehab H Werida, Lecturer	Clinical Pharmacy Lecturer	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
al Mowassah Hospital		Alexandria		21500	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15216492	Background	London GM, Marchais SJ, Guerin AP. Arterial stiffness and function in end-stage renal disease. Adv Chronic Kidney Dis. 2004 Apr;11(2):202-9. doi: 10.1053/j.arrt.2004.02.008.
19491380	Background	Sigrist MK, Levin A, Er L, McIntyre CW. Elevated osteoprotegerin is associated with all-cause mortality in CKD stage 4 and 5 patients in addition to vascular calcification. Nephrol Dial Transplant. 2009 Oct;24(10):3157-62. doi: 10.1093/ndt/gfp253. Epub 2009 Jun 2.

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

ID	Term
D015525	Fatty Acids, Omega-3
D005395	Fish Oils

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids