NCT02652338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

December 16, 2015

Last Update Submit

January 7, 2016

Conditions

Cardiac Arrhythmia

Keywords

heart rhythm disturbances and symptomsdietary supplement

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the changes in the perception of six symptoms

    at baseline, at follow-up visit 4 (at the end of week three) and at follow-up visit 5 (at the end of study) by visual analogue scale \[VAS\]: complete summary to a total score value in comparison to baseline

    end week 3 and week 6

Secondary Outcomes (8)

  • symptom awareness and responder rate

    end week 6

  • symptom awareness and changes during the study

    end week 3 and week 6

  • absolute reduction in premature ventricular beat (PVB)

    end week 3 and 6 week

  • relative reduction of the premature ventricular beat (PVB)

    end week 3 and week 6

  • responder rate of the premature ventricular beat (PVB)

    end week 3 and week 6

  • +3 more secondary outcomes

Study Arms (2)

MNC-01

ACTIVE COMPARATOR

potassium, magnesium, and vitamins (MNC-01)

Dietary Supplement: MNC-01

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

MNC-01DIETARY_SUPPLEMENT

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

MNC-01
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elke Parsi assoc. Prof. MD

Berlin, State of Berlin, 13053, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30509185DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christine Metzner, Prof. MD

    Bonn Education Association for Dietetics r. A.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief Executive Officer, Bonn Education Association for Dietetics r.A., Cologne, Germany

Study Record Dates

First Submitted

December 16, 2015

First Posted

January 11, 2016

Study Start

April 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

DE(1)