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Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients

NCT ID: NCT00749307

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to test the hypothesis that dietary supplementation with an algal source of docosahexaenoic acid (DHA) can improve the heart rate variability in elderly patients.

Detailed Description

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In western countries, sudden cardiac death (SCD) represents the most common form of cardiovascular death. SCD is often caused by ventricular arrhythmias in patients with a known history of ischemic heart disease but it may also occurs in healthy persons.

In the last years has been extensively studied the protective role of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) against SCD both in healthy persons and in patients affected by coronary artery disease.

The hypothesis that these evidences could be ascribed to an antiarrhythmic effect of n-3 LCPUFA, has been corroborated by the observation of a direct relationship between the dietary intake of these nutrients and a better cardiac autonomic control.

This pathway, in particular, has been confirmed by the analysis of changes in heart rate variability.

Most studies in this field used n-3 LCPUFA derived from fish oil, composed by a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). At our knowledge there are few studies available evaluating the isolated role of DHA, derived from alternative sources of n-3 LCPUFA, as the microalgae, in the prevention of fatal arrhythmias.

Conditions

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Arrhythmia

Keywords

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Heart rate variability Docosahexaenoic acid DHA Long chain fatty acids Long chain polyunsaturated fatty acids Algal fatty acids Schizochytrium Omega 3 Death, Sudden, Cardiac Arrhythmias, Cardiac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Docosahexaenoic acid (DHA)

Intervention Type DIETARY_SUPPLEMENT

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Docosahexaenoic acid (DHA)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age above 65 years

Exclusion Criteria

* Treatment with or allergy to polyunsaturated fatty acids
* Diagnosis of arrhythmia or antiarrhythmic therapy
* Anticoagulant therapy (except acetylsalicylic acid)
* Pacemaker
* Bleeding diathesis
* Recent cerebral hemorrhage (less than 6 months)
* Thyroid dysfunction
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role collaborator

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

Pharmanutra s.r.l.

UNKNOWN

Sponsor Role collaborator

Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Campus Bio-Medico University

Principal Investigators

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Raffaele Antonelli Incalzi, MD

Role: STUDY_DIRECTOR

Campus Bio-Medico University

Giuseppe Rosano, MD

Role: STUDY_DIRECTOR

IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.

Francesco M Serino, MD

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Marco Miceli, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele Pisana. Department of Sciences. Cardiovascular Research Unit.

Locations

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IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.

Rome, RM, Italy

Site Status

Countries

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Italy

Other Identifiers

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EudraCT number 2008-005715-18

Identifier Type: -

Identifier Source: secondary_id

ALFAHRV01

Identifier Type: -

Identifier Source: org_study_id