Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

NCT ID: NCT01480687

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension Hypertriglyceridemia

Keywords

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Hypertension Endothelial dysfunction Vascular stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Omega-3 fatty acid

Group Type EXPERIMENTAL

DHA-EPA

Intervention Type DIETARY_SUPPLEMENT

1800 mg/day

Ciprofibrate

Group Type ACTIVE_COMPARATOR

Ciprofibrate

Intervention Type DRUG

100 mg/day

Interventions

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DHA-EPA

1800 mg/day

Intervention Type DIETARY_SUPPLEMENT

Ciprofibrate

100 mg/day

Intervention Type DRUG

Other Intervention Names

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OMEVITS LIPLESS

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role lead

Responsible Party

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Mario Fritsch Neves

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcela A Casanova, MSc

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Mario F Neves, MD, PhD

Role: STUDY_CHAIR

State University of Rio de Janeiro

Wille Oigman, MD, PhD

Role: STUDY_CHAIR

State University of Rio de Janeiro

Fernanda J Medeiros, PhD

Role: STUDY_CHAIR

Federal University of the State of Rio de Janeiro

Locations

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Hospital Universitario Pedro Ernesto

Rio de Janeiro, RJ, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Marcela A. Casanova, MSc

Role: CONTACT

Phone: 55-21-2868-8484

Email: [email protected]

Mario F. Neves, MD, PhD

Role: CONTACT

Phone: 55-21-2868-8485

Email: [email protected]

Facility Contacts

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Marcela A Casanova, MSc

Role: primary

Other Identifiers

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FO-1800

Identifier Type: -

Identifier Source: org_study_id