Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01480687
• Other study ID #: FO-1800
• Status: Recruiting
• Phase: Phase 4
• First received: June 22, 2011
• Last updated: November 23, 2011
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Hospital Universitario Pedro Ernesto
• Contact: Marcela A. Casanova, MSc
• Phone: 55-21-2868-8484
• Email: cela.abreu[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertriglyceridemia

Intervention

Dietary Supplement:
• DHA-EPA
1800 mg/day

Drug:
• Ciprofibrate
100 mg/day

Locations

Country	Name	City	State
Brazil	Hospital Universitario Pedro Ernesto	Rio de Janeiro, RJ	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	Endothelial function evaluated by brachial flow-mediated dilation and by peripheral arterial tonometry.	3 months	No