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

NCT ID: NCT02652338

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MNC-01

potassium, magnesium, and vitamins (MNC-01)

Group Type: ACTIVE_COMPARATOR

MNC-01

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

cellulose, microcrystalline \[NF\], HPMC E15,

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

MNC-01

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• PVB in the long-term ECG recording (registration at least 18 hours): at least 500 PVB/24 h or Supraventricular tachycardia (≥10 episodes/24h, outside sporting activity) or SVPB with vegetative symptoms (increased sweating, inner unrest, shaky hands, red dermographism) and no cardial pretreatment

Exclusion Criteria

• Left ventricular ejection fraction [EF] ≤ 40 %
• Therapy with spironolactone > 50 mg/d
• Therapy with torasemide > 20 mg/d
• Supplementation or therapy with dietary supplements or drugs which contain vitamins and minerals (above all potassium and magnesium)
• Creatinine in the serum [i. S.]:≥ 1,4 mg/dl (men), ≥ 1,2 mg/dl (women)
• Potassium i. S. ≤ 3,4 mmol/l and > 5,4 mmol/l
• Magnesium i. S. ≤ 0,7 mmol/l and > 1,0 mmol/l
• Acute and chronic diarrhea
• Hyperthyroidism anamnestic or due to the current TSH (thyroid stimulating hormone)-value
• Pacemaker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Trommsdorff GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Christine Metzner Prof. Dr. Dr.

chief Executive Officer, Bonn Education Association for Dietetics r.A., Cologne, Germany

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Metzner, Prof. MD

Role: STUDY_CHAIR

Bonn Education Association for Dietetics r. A.

Locations

Elke Parsi assoc. Prof. MD

Berlin, State of Berlin, Germany

Countries

Germany

References

Parsi E, Bitterlich N, Winkelmann A, Rosler D, Metzner C. Dietary intervention with a specific micronutrient combination for the treatment of patients with cardiac arrhythmias: the impact on insulin resistance and left ventricular function. BMC Cardiovasc Disord. 2018 Dec 3;18(1):220. doi: 10.1186/s12872-018-0954-6.

Reference Type: DERIVED

PMID: 30509185 (View on PubMed)

Other Identifiers

MNC-01

Identifier Type: -

Identifier Source: org_study_id