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

N

New York Hospital Queens

Status and phase

Unknown
Phase 2

Conditions

Dyslipidemia

Treatments

Other: VASCAZEN

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Vascazen
Experimental group
Description:
Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks.
Treatment:
Other: VASCAZEN

Trial contacts and locations

1

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Central trial contact

Brian S Marino, DO; Donna Cheslik, RN, MSN

Data sourced from clinicaltrials.gov

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