NCT00749307

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

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

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

1.3 years

First QC Date

September 8, 2008

Last Update Submit

November 24, 2009

Conditions

Arrhythmia

Keywords

Heart rate variabilityDocosahexaenoic acidDHALong chain fatty acidsLong chain polyunsaturated fatty acidsAlgal fatty acidsSchizochytriumOmega 3Death, Sudden, CardiacArrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability (HRV)

    basal - 12 weeks - 30 weeks

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: Docosahexaenoic acid (DHA)

2

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Docosahexaenoic acid (DHA)DIETARY_SUPPLEMENT
1
PlaceboDIETARY_SUPPLEMENT
2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age above 65 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rome, RM, 00163, Italy

Location

MeSH Terms

Conditions

Arrhythmias, CardiacDeath, Sudden, Cardiac

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestDeath, SuddenDeath

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Raffaele Antonelli Incalzi, MD

    Campus Bio-Medico University

    STUDY DIRECTOR

  • Giuseppe Rosano, MD

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

    STUDY DIRECTOR

  • Francesco M Serino, MD

    Campus Bio-Medico University

    PRINCIPAL INVESTIGATOR

  • Marco Miceli, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2009

Study Completion

November 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

IT(1)