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

This study has been completed.
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University Identifier:
First received: July 12, 2012
Last updated: February 2, 2016
Last verified: February 2016
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Reduction of the ventricular and atrial arrhythmias. [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in life quality [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diagnosis of ventricular or atrial extrasystoles

Exclusion Criteria:

  • Presence of organic cardiomyopathy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01647984

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

Additional Information:
Responsible Party: Bruno Trimarco, Full Professor of Cardiology, Federico II University Identifier: NCT01647984     History of Changes
Other Study ID Numbers: RITMONUTRA 2012 
Study First Received: July 12, 2012
Last Updated: February 2, 2016
Health Authority: Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by Federico II University:
Life quality

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Vitamin E
Growth Substances
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on February 07, 2016