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Dietary Supplement on Symptom Awareness and Heart Rhythm in Patients With Cardiac Arrhythmia

NCT02652338 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2016-01-11

No results posted yet for this study

Summary

The main aim of this study, which was carried out in two parallel groups, is testing the efficacy of a specific micronutrients combination in adults with heart rhythm disturbances and accompanying symptoms.

It is therefore the investigators hypothesis that daily oral administration of the specific micronutrients combination will lead to a decrease of symptoms awareness and to a reduction of heart rhythm disturbances in adults with or without structural heart disease. The principal endpoints will be a decrease in the total score of symptoms awareness.

Conditions

  • Cardiac Arrhythmia

Interventions

DIETARY_SUPPLEMENT

MNC-01

twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks

DIETARY_SUPPLEMENT

Placebo

twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks

Sponsors & Collaborators

  • Bonn Education Association for Dietetics r.A., Cologne, Germany

    collaborator INDUSTRY

  • Trommsdorff GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Christine Metzner, Prof. MD · Bonn Education Association for Dietetics r. A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652338 on ClinicalTrials.gov