NCT00192543

Brief Summary

Cardiovascular disease is the main cause of death in patients on dialysis for end stage renal disease. Omega-3 fatty acids and antioxidants have been shown to be protective in the general population. A diet of fish and fruit, which will provide the fatty acids and the antioxidants is being tried in dialysis patients to assess the effect on cardiovascular disease in this high risk group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at below P25 for phase_3 cardiovascular-diseases

Timeline
Completed

Started May 2004

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

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 4, 2011

Status Verified

March 1, 2009

Enrollment Period

4.6 years

First QC Date

September 11, 2005

Last Update Submit

August 3, 2011

Conditions

Cardiovascular Diseases

Keywords

dialysisomega-3 fatty acidsantioxidantscardiovascular markersMortalityEnd-stage renal disease

Outcome Measures

Primary Outcomes (1)

  • Deaths due to cardiovascular disease

    records continue to be checked till 2009

Secondary Outcomes (1)

  • Non-invasive cardiovascular markers: carotid intimal medial thickness

    completed 2008

Study Arms (2)

case

ACTIVE COMPARATOR

diet of fish and fruit addition compared to regular diet

Behavioral: diet of fish and fruitBehavioral: diet only

control

PLACEBO COMPARATOR

regular diet

Behavioral: fruit and fishBehavioral: regular diet

Interventions

diet of fish and fruitBEHAVIORAL

fish and fruit in specified quantities

Also known as: regular diet
case
fruit and fishBEHAVIORAL

no drugs

control
diet onlyBEHAVIORAL

Fish and fruit

case
regular dietBEHAVIORAL

no change in regular diet

control

Eligibility Criteria

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

You may qualify if:

  • All patients on hemodialysis

You may not qualify if:

  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health and Community Services

Darwin, Northern Territory, 0810, Australia

Location

MeSH Terms

Conditions

Cardiovascular DiseasesKidney Failure, Chronic

Interventions

FruitDietIn Situ Hybridization, Fluorescence

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesNutritional Physiological PhenomenaIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid Hybridization

Study Officials

  • Kerin O'Dea, PhD

    Menzies School of Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

May 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 4, 2011

Record last verified: 2009-03

Locations

AU(1)