Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000158864
Ethics application status
Approved
Date submitted
3/02/2012
Date registered
3/02/2012
Date last updated
9/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Fish oil supplementation as adjunct therapy for chronic obstructive pulmonary disease (COPD): A feasibility study
Scientific title
A double-blind, randomised, placebo-controlled trial to evaluate the feasibility of omega 3 fatty acid supplementation for reducing inflammation and improving functional exercise capacity in patients with chronic obstructive pulmonary disorder (COPD).
Secondary ID [1] 279783 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 285661 0
Inflammation 285761 0
Condition category
Condition code
Respiratory 285841 285841 0 0
Chronic obstructive pulmonary disease
Inflammatory and Immune System 285938 285938 0 0
Other inflammatory or immune system disorders
Alternative and Complementary Medicine 285945 285945 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double-blind, randomised, placebo-controlled intervention trial designed to evaluate whether fish oil supplementation (6 x 1g/day for 4 months) can reduce inflammation and mediate improvements in functional exercise capacity in patients with chronic obstructive pulmonary disorder (COPD). Forty volunteers will be recruited through public advertisements and from a patient database maintained by the Department of Respiratory Medicine in the Southern Adelaide Health Network. They will have a clinical and spirometric diagnosis of COPD. Prior to the commencement of the study volunteers will complete a series of questionnaires and tests designed to assess lung and physical function, diet history and quality of life. Blood samples will be collected and assayed for dietary and inflammatory biomarkers. Volunteers will be randomised to to one of two groups: 1. Fish oil - 6 x 1g capsules (approximately 3.6g/day long chain omega-3 polyunsaturated fatty acids) 2. Placebo - 6 x 1g capsules (corn oil) Functional and biochemical assessments will be repeated at four months following commencement. A symptom diary will be used to assess frequency and severity of exacerbation symptoms during the study. Upon completion of the study participant experience and perspectives will be gathered using a structured telephone interview.
Intervention code [1] 284160 0
Lifestyle
Intervention code [2] 284185 0
Treatment: Other
Comparator / control treatment
Corn oil supplemetns (6 x 1g/day)
Control group
Placebo

Outcomes
Primary outcome [1] 289494 0
The incorporation of long chain omega-3 fatty acids in erythrocytes will be measured by gas chromatography following fatty acid extraction from red blood cells
Timepoint [1] 289494 0
Baseline (week 0) and 4 months
Secondary outcome [1] 295782 0
Functional exercise capacity assessed by the six minute walk test
Timepoint [1] 295782 0
Baseline (week 0) and 4 months
Secondary outcome [2] 295785 0
Respiratory impairment assessed by pulmonary function tests
Timepoint [2] 295785 0
Baseline (week 0) and 4 months
Secondary outcome [3] 295861 0
Sensation of dyspnoea (sensory quality, intensity and unpleasantness) will be assessed using the Dyspnoea-12 and two 10cm visual analogue scales
Timepoint [3] 295861 0
Baseline (week 0) and 4 months
Secondary outcome [4] 295862 0
The incorporation of long chain omega-3 fatty acids in erythrocytes will be measured by gas chromatography following fatty acid extraction from red blood cells.
Timepoint [4] 295862 0
Baseline (week 0) and 4 months
Secondary outcome [5] 295863 0
Anxiety and depression will be assessed by the Hopsital Anxiety and Depression Scale (HADS)
Timepoint [5] 295863 0
Baseline (week 0) and 4 months
Secondary outcome [6] 302608 0
Health related quality of life will be assesed by the Chronic Respiratory Questionnaire (CRQ)
Timepoint [6] 302608 0
Baseline (week 0) and 4 months
Secondary outcome [7] 302609 0
Dietary intake will be assessed using the Victorian Cancer Council Food Frequency Questionnaire
Timepoint [7] 302609 0
Baseline (week 0 ) and 4 months
Secondary outcome [8] 302610 0
TNF alpha, IL-1 beta, IL-6, IL-10 and HsCRP measured by multiplex analyser from fasted blood samples
Timepoint [8] 302610 0
Baseline (week 0) and 4 months

Eligibility
Key inclusion criteria
1. Aged between 18-80 years
2. Have a clinical and spirometric diagnosis of COPD (forced expiratory volume (FEV1) <80% of predicted and best recorded ratio of FEV1 to forced vital capacity (FEV1/FVC) <0.70)
3.Stable dose of medication for 28 days prior to entering the study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of fish oil (>1g/day for 3 months); 2. Self-reported presence of unstable co morbidities (right heart failure, sleep disorders, metabolic pathologies); 3. Current smoker; 4. GOLD stage IV COPD (due to the high likelihood of irreversible airways remodelling); 5. a-antitrypsin deficiency; 6. Cachexia (unintentional weight loss exceeding 5% within the previous 3-12 months) or body mass index (BMI) < 18.5kg/m2; 7. Morbid obesity (BMI >40kg/m2); 8. A mini mental assessment score of <23 to ensure that participants are cognitively able to complete assessments; 9. Clinically unstable COPD; 10. Use of steroid or antibiotic medication for 28 days prior to baseline visit; 11. Patients with respiratory conditions not related to airflow limitation (e.g. primary pulmonary hypertension, post-lobectomy for lung cancer, or pulmonary fibrosis); 12. Participation in a comprehensive pulmonary rehabilitation program in the previous 2 years; 13. Intending to undertake a pulmonary rehabilitation program in the next 6 months. 14. Use of Warfarin medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects meeting entry criteria at screening will be allocated to a treatment at random using a minimisation procedure. Allocation will be performed by contacting the holder of the allocation schedule who is “off-site”, and who will not be involved in screening.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be based on the modified Medical Research Council (mMRC) dyspnoea scale score at baseline.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
29/04/2013
Actual
13/06/2013
Date of last participant enrolment
Anticipated
Actual
5/05/2015
Date of last data collection
Anticipated
Actual
5/05/2015
Sample size
Target
40
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 6815 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 284621 0
University
Name [1] 284621 0
University of South Australia
Country [1] 284621 0
Australia
Primary sponsor type
Individual
Name
Dr. Alison Hill
Address
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 283549 0
University
Name [1] 283549 0
University of South Australia
Address [1] 283549 0
Division of Health Science
City East Campus
GPO Box 2471
Adelaide SA 5001
Australia
Country [1] 283549 0
Australia
Other collaborator category [1] 260489 0
Individual
Name [1] 260489 0
Dr Alison Coates
Address [1] 260489 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country [1] 260489 0
Australia
Other collaborator category [2] 260490 0
Individual
Name [2] 260490 0
Professor Peter Frith
Address [2] 260490 0
Repatriation General Hospital
Respiratory Medicine
Daws Road Daw Park SA 5041
Country [2] 260490 0
Australia
Other collaborator category [3] 260491 0
Individual
Name [3] 260491 0
Associate Professor Marie Williams
Address [3] 260491 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country [3] 260491 0
Australia
Other collaborator category [4] 260493 0
Individual
Name [4] 260493 0
Prfessor Manohar Garg
Address [4] 260493 0
Priority Research Centre in physical Activity and Nutrition
School of Biomedical Sciences and Pharmacy
University of Newcastle
University Drive Callaghan NSW 2308
Country [4] 260493 0
Australia
Other collaborator category [5] 260494 0
Individual
Name [5] 260494 0
Dr. Lisa Wood
Address [5] 260494 0
Priority Research Centre for Asthma & Respiratory Diseases
School of Biomedical Sciences and Pharmacy
University of Newcastle
University Drive Callaghan NSW 2308
Country [5] 260494 0
Australia
Other collaborator category [6] 260497 0
Individual
Name [6] 260497 0
Professor Peter Howe
Address [6] 260497 0
Nutritional Physiology Research Centre, Sansom Institute for Health Research, School of Health Sciences, University of South Australia, City East Campus, Frome Road, Adelaide, South Australia 5000, Australia.
Clinical Nutrition Research Centre, School of Biomedical Sciences & Pharmacy, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia
Country [6] 260497 0
Australia
Other collaborator category [7] 277790 0
Individual
Name [7] 277790 0
Ashley Fulton
Address [7] 277790 0
Nutritional Physiology Research Centre, School of Health Sciences University of South Australia PO Box 2471 Adelaide SA 5001
Country [7] 277790 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286613 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 286613 0
Ethics committee country [1] 286613 0
Australia
Date submitted for ethics approval [1] 286613 0
28/11/2011
Approval date [1] 286613 0
23/04/2012
Ethics approval number [1] 286613 0
0000026302
Ethics committee name [2] 289203 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [2] 289203 0
Ethics committee country [2] 289203 0
Australia
Date submitted for ethics approval [2] 289203 0
Approval date [2] 289203 0
22/03/2013
Ethics approval number [2] 289203 0
208.12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33670 0
Dr Alison Hill
Address 33670 0
Nutritional Physiology Research Centre, Sansom Institute for Health Research, School of Health Sciences, University of South Australia, City East Campus, Frome Road, Adelaide, South Australia 5000, Australia.
Country 33670 0
Australia
Phone 33670 0
+61 8 8302 1817
Fax 33670 0
Email 33670 0
alison.hill@unisa.edu.au
Contact person for public queries
Name 16917 0
Alison Hill
Address 16917 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country 16917 0
Australia
Phone 16917 0
+61 08 8302 1817
Fax 16917 0
+61 08 8302 2178
Email 16917 0
alison.hill@unisa.edu.au
Contact person for scientific queries
Name 7845 0
Alison Hill
Address 7845 0
Nutritional Physiology Research Centre
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country 7845 0
Australia
Phone 7845 0
+61 08 8302 1817
Fax 7845 0
+61 08 8302 2178
Email 7845 0
alison.hill@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility of omega-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial.2013
EmbaseFeasibility of omega-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial.2013https://dx.doi.org/10.1186/1745-6215-14-107
Dimensions AIFish oil supplementation in chronic obstructive pulmonary disease: feasibility of conducting a randomised controlled trial2017https://doi.org/10.1186/s40814-017-0211-2
N.B. These documents automatically identified may not have been verified by the study sponsor.