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Role of a Combination of Nutraceuticals (Ritmonutra) on Benign Supraventricular and Ventricular Arrhythmias

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University
ClinicalTrials.gov Identifier:
NCT01647984
First received: July 12, 2012
Last updated: February 2, 2016
Last verified: February 2016
  Purpose
Study on the role of a combination of nutraceuticals (Ritmonutra) with an effect on benign supraventricular and ventricular extrasystoles in subjects free of a specific organic heart disease. It has been suggested treatment with a nutritional supplement, able to normalize the 'cardiac electrophysiology' and help to maintain wellness. Ritmonutra ® is a combination of nutraceuticals®, including Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin and Vitamin E, help to normalize the heart pacing, reducing the total number of benign extrasystoles and consequently improving the quality of life.

Condition Intervention Phase
Ventricular and Atrial Extrasytoles Dietary Supplement: Ritmonutra Dietary Supplement: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Study on the Role of a Combination of Nutraceuticals (Ritmonutra) With an Effect on Benign Supraventricular and Ventricular Arrhythmias in Subjects Free of a Specific Organic Heart Disease.

Further study details as provided by Bruno Trimarco, Federico II University:

Primary Outcome Measures:
  • Reduction of the ventricular and atrial arrhythmias. [ Time Frame: 4 week ]

Secondary Outcome Measures:
  • Improvement in life quality [ Time Frame: 4 week ]

Enrollment: 1500
Study Start Date: December 2012
Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Inert Placebo - Vitamin B complex + diet
Dietary Supplement: placebo
Active Comparator: Ritmonutra
Omega-3 polyunsaturated fatty acids, Hawthorn, Astaxanthin, Vitamin E, Vitamin B complex + diet
Dietary Supplement: Ritmonutra
Ritmonutra ® contains: 720 mg of Fish Oil with Omega-3, including 480 mg of EPA and 40 mg of DHA, Hawthorn (extract from Crataegus mongyna) 300 mg equivalent to 5.4 mg of vitexin, 4 mg of Astaxanthin and 36 mg of Vitamin E
Other Names:
  • Omega-3 polyunsaturated fatty acids
  • Hawthorn
  • Astaxanthin
  • Vitamin E
  • Vitamin B complex
  • Diet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of ventricular or atrial extrasystoles

Exclusion Criteria:

  • Presence of organic cardiomyopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647984

Locations
Italy
Ambulatorio Ipertensione e Unità Coronarica Federico II University
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Study Director: Bruno Trimarco, MD Federico II University, Dipartimento di medicina Clinica Scienze Cardiovascolari ed Immunologiche
  More Information

Additional Information:
Publications:
Responsible Party: Bruno Trimarco, Full Professor of Cardiology, Federico II University
ClinicalTrials.gov Identifier: NCT01647984     History of Changes
Other Study ID Numbers: RITMONUTRA 2012
Study First Received: July 12, 2012
Last Updated: February 2, 2016

Keywords provided by Bruno Trimarco, Federico II University:
Arrhythmias
Life quality

Additional relevant MeSH terms:
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Folic Acid
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hematinics

ClinicalTrials.gov processed this record on July 24, 2017