An Open-Label Study of Vascazen in Cardiac Rehab Patients With Deficient Blood Omega-3 Fatty Acid Levels

Phase 2

• Conditions: Dyslipidemia
• Interventions: Other: VASCAZEN

• Registration Number: NCT02052986
• Lead Sponsor: New York Hospital Queens

Brief Summary

The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-16
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-31
• Last Update Submitted: 2014-01-31
• Study First Posted: 2014-02-03
• Last Update Posted: 2014-02-03
• Primary Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult subjects (> or = 18 years of age)
• Enrolled in Cardiac Rehabilitation clinic with documented cardiovascular disease as assessed by the principle investigator
• Has had cardiovascular examination within the past 2 months

Exclusion Criteria

• Subjects who refuse to provide written consent
• Subjects with medical conditions, as determined by the principal investigator, which prevented them from study participation
• Subjects with a known bleeding or clotting disorder
• Subjects with known allergies to fish
• Subjects with an implantable cardiac defibrillator
• Subjects with a heart transplant
• Female subjects who are currently taking hormone replacement therapy
• Subjects who are pregnant or planning on becoming pregnant
• Subjects currently taking Omega-3 fatty acid supplements (either under medical supervision or self-administered)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vascazen	VASCAZEN	Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in sum of Omega-Score and Omega-Index	12 weeks	Change in the sum of the subject's blood Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) + Docosapentaenoic acid (DPA) levels (Omega-Score) and the change in the sum of the subject's red blood cell (RBC) EPA + DHA levels (Omega-Index) over 12 weeks of study treatment with Vascazen

Secondary Outcome Measures

Name	Time	Method
Change in patient health questionnaire-9 (PHQ-9) depression scale	12 weeks	Change in patient health questionnaire-9 (PHQ-9) depression scale after 12 weeks of study treatment

Trial Locations

Locations (1)

The NYHQ Cardiac Health Center; 🇺🇸 Fresh Meadows, New York, United States