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Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

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ClinicalTrials.gov Identifier: NCT01480687
Recruitment Status : Unknown
Verified November 2011 by Mario Fritsch Neves, Hospital Universitario Pedro Ernesto.
Recruitment status was:  Recruiting
First Posted : November 29, 2011
Last Update Posted : November 29, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Hypertriglyceridemia Dietary Supplement: DHA-EPA Drug: Ciprofibrate Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia
Study Start Date : May 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Omega-3 fatty acid Dietary Supplement: DHA-EPA
1800 mg/day
Other Name: OMEVITS
Active Comparator: Ciprofibrate Drug: Ciprofibrate
100 mg/day
Other Name: LIPLESS

Outcome Measures

Primary Outcome Measures :
  1. Endothelial function [ Time Frame: 3 months ]
    Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480687

Contact: Marcela A. Casanova, MSc 55-21-2868-8484 cela.abreu@gmail.com
Contact: Mario F. Neves, MD, PhD 55-21-2868-8485 mariofneves@gmail.com

Hospital Universitario Pedro Ernesto Recruiting
Rio de Janeiro, RJ, Rio de Janeiro, Brazil
Contact: Marcela A Casanova, MSc    55-21-2868-8484    cela.abreu@gmail.com   
Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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
More Information

Responsible Party: Mario Fritsch Neves, MD, PhD, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01480687     History of Changes
Other Study ID Numbers: FO-1800
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: November 29, 2011
Last Verified: November 2011

Keywords provided by Mario Fritsch Neves, Hospital Universitario Pedro Ernesto:
Endothelial dysfunction
Vascular stiffness

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents