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

NCT03982966 | Completed DMC

• 1 other identifier: omega 3 fatty acids on CRF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (2)

• Feutin-A Level

  vascular calcification biomarkers

  six months

• Osteoprotegrin

  vascular calcification biomarkers

  six months

Study Arms (2)

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

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

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

Omega 3

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

al Mowassah Hospital

Alexandria, 21500, Egypt

Location

Related Publications (2)

• 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.

  PMID: 15216492 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.

  PMID: 19491380 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Study Officials

• Rehab H Werida, Lecturer

  Clinical Pharmacy Lecturer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Lecturer

Model Details: 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 served as control will not take omega 3 fatty acids.

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: June 12, 2019
• Study Start: January 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)