Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

November 23, 2011 updated by: Mario Fritsch Neves, Hospital Universitario Pedro Ernesto

Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia

The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty acid supplementation on the vascular structure and function in hypertensive patients with hypertriglyceridemia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hypertensive patients aged 40-65 years, both genders, presenting serum triglycerides levels higher than 150 mg/dl will be randomized into two groups. The first group will be receiving ciprofibrate 100mg/day and the second group will be receiving fish oil 1800mg/day. All patients will be evaluated with brachial flow-mediated dilation and with EndoPAT to assess endothelial function before and after supplementation. SPHYGMOCOR and pulse wave velocity (PWV) measurements will also be obtained.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, RJ, Rio de Janeiro, Brazil
        • Recruiting
        • Hospital Universitário Pedro Ernesto
        • Contact:

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous diagnosis of hypertension
  • Patients with serum triglycerides levels ≥ 150 mg/dl and <500 mg/dl
  • Patients on stable antihypertensive medication for at least 4 weeks
  • Patients with food consumption maintained for at least 4 weeks

Exclusion Criteria:

  • Smoking
  • Secondary hypertension
  • Hormone replacement therapy
  • Diabetes mellitus
  • Chronic kidney disease
  • Known coronary artery disease
  • Previous stroke
  • Dyslipidemia severe, with LDL cholesterol> 160 mg/dL or triglycerides ≥ 500 mg/dl
  • Use of statins or beta blockers

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 fatty acid
Dietary supplement: DHA-EPA
1800 mg/day
Other Names:
  • OMEVITS
Active Comparator: Ciprofibrate
Drug: Ciprofibrate
100 mg/day
Other Names:
  • LIPLESS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: 3 months
Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.
3 months

Collaborators and Investigators

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

Sponsor

Hospital Universitario Pedro Ernesto

Collaborators

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

  • Principal Investigator: Marcela A Casanova, MSc, State University of Rio de Janeiro
  • Study Chair: Mario F Neves, MD, PhD, State University of Rio de Janeiro
  • Study Chair: Wille Oigman, MD, PhD, State University of Rio de Janeiro
  • Study Chair: Fernanda J Medeiros, PhD, Federal University of the State of Rio de Janeiro

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

May 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 23, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FO-1800

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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