Back to resultsEffects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
Primary Purpose
Arrhythmia
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Docosahexaenoic acid (DHA)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Arrhythmia focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Heart rate variability (HRV)
Secondary Outcome Measures
Full Information
NCT ID
NCT00749307
First Posted
September 8, 2008
Last Updated
November 24, 2009
Sponsor
Campus Bio-Medico University
Collaborators
IRCCS San Raffaele, DSM Nutritional Products, Inc., Pharmanutra s.r.l.
1. Study Identification
Unique Protocol Identification Number
NCT00749307
Brief Title
Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
Official Title
Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Campus Bio-Medico University
Collaborators
IRCCS San Raffaele, DSM Nutritional Products, Inc., Pharmanutra s.r.l.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexaenoic acid (DHA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Heart rate variability (HRV)
Time Frame
basal - 12 weeks - 30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaele Antonelli Incalzi, MD
Organizational Affiliation
Campus Bio-Medico University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giuseppe Rosano, MD
Organizational Affiliation
IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francesco M Serino, MD
Organizational Affiliation
Campus Bio-Medico University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco Miceli, MD
Organizational Affiliation
IRCCS San Raffaele Pisana. Department of Sciences. Cardiovascular Research Unit.
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
City
Rome
State/Province
RM
ZIP/Postal Code
00163
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
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