Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000241235
Ethics application status
Approved
Date submitted
9/02/2009
Date registered
11/05/2009
Date last updated
3/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a moderate dose fish oil intervention improve outcomes in older adults recovering from hip fracture?
Scientific title
A Trial Assessing omega-3 fatty acids (N-3) as Treatment for Injury-induced Cachexia
Secondary ID [1] 252326 0
ATLANTIC
Universal Trial Number (UTN)
Trial acronym
ATLANTIC trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly hip fracture patients with malnutrition 4269 0
Condition category
Condition code
Injuries and Accidents 4495 4495 0 0
Fractures
Diet and Nutrition 4496 4496 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-week well integrated, coordinated, individualized nutrition therapy plan consistent with estimated nutritional requirements and nutritional rehabilitation goals combined with moderate dose liquid fish oil intervention (20ml/d; 3g eicosapentanoic acid (EPA) and 2g docosahexanoic acid (DHA)
Intervention code [1] 3995 0
Treatment: Other
Comparator / control treatment
The comparator group will receive the identical individualized 12-week nutrition therapy plan as the intervention group combined with low dose liquid fish oil (20ml/d; 0.3g EPA and 0.2g DHA)
Control group
Dose comparison

Outcomes
Primary outcome [1] 5377 0
Health-related quality of life as assessed by the 'Assessment of Quality of Life' (AQoL) tool
Timepoint [1] 5377 0
At 6 and 12 weeks
Secondary outcome [1] 9041 0
Body composition, assessed by dual-energy x-ray absorptiometry and bioelectrical impedance analysis
Timepoint [1] 9041 0
At 6 and 12 weeks
Secondary outcome [2] 9042 0
Physical function, assessed by timed chair stand test and assessment of physical autonomy by the 'Activities of Daily Living' tool
Timepoint [2] 9042 0
At 6 and 12 weeks
Secondary outcome [3] 9043 0
Levels of inflammatory markers including: C-reactive protein (CRP), Interleukin-1 (IL-1), Interleukin-6 (IL6) and tumour necrosis factor alpha (TNF-alpha)
Adherence to the fish oil intervention will be assessed by analysis of essential fatty acids (EPA ad DHA) from the erythrocyte phospholipid membrane
Timepoint [3] 9043 0
At 6 and 12 weeks
Secondary outcome [4] 241658 0
Nutritional status, assessed by the Mini Nutritional Assessment and percent weight change
Timepoint [4] 241658 0
At 6 and 12 weeks
Secondary outcome [5] 241659 0
Resting energy expenditure (REE), assessed by a hand held portable indirect calorimeter.
Timepoint [5] 241659 0
At 6 and 12 weeks

Eligibility
Key inclusion criteria
- Aged >65 years
- PFF confirmed by radiology report
- Undergone surgery for fixation of hip fracture
- Reside within existing local service boundaries
- Community dwelling
- Preliminary evidence of cachexia (CRP =6mg/L)
- At risk of significant weight loss (SNAQ score =14/20)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe cognitive impairment (MMSE <18/30)

- PFF not fall-related, is pathological or is peri-prosthetic

- Initiation of anti-inflammatory drugs or corticosteroids within the previous two weeks

- Ingestion of =2g total omega-3 daily as per fish FFQ

- Seafood allergy

- Life expectancy <12 weeks

- Inability to communicate effectively due to blindness, deafness or lack of a translator

- Inability to provide informed consent

- Diagnosed with one of the following haemorrhagic stroke risk factors (Unstable hypertension, Atrial fibrillation, Inherited disorders such as polycystic kidney disease, Ehlers-Danlos syndrome type IV, neurofibromatosis type I, Marfan syndrome, moyamoya disease)

- Diagnosed with a bleeding disorders such as the following (von Willebrand disease or Haemophilia

- Receiving treatment doses of any antithrombotic agent

- Those on dual anti-platelet function drugs or any anti-platelet drugs with exception to low dose aspirin.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Double-blinded trial
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4453 0
Government body
Name [1] 4453 0
National Health and Medical Research Council (NHMRC)
Country [1] 4453 0
Australia
Primary sponsor type
Individual
Name
Dr Michelle Miller
Address
Department of Nutrition and Dietetics, Flinders University, GPO Box 2100, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 4012 0
Individual
Name [1] 4012 0
Professor Maria Crotty
Address [1] 4012 0
Department of Rehabilitation and Aged Care, Flinders University, GPO Box 2100, Adelaide SA 5001
Country [1] 4012 0
Australia
Other collaborator category [1] 553 0
Individual
Name [1] 553 0
Associate Professor Robert Fraser
Address [1] 553 0
Department of Medicine, Flinders University, GPO Box 2100, Adelaide SA 5001
Country [1] 553 0
Australia
Other collaborator category [2] 554 0
Individual
Name [2] 554 0
Professor Lynne Cobiac
Address [2] 554 0
Department of Nutrition and Dietetics, Flinders University, GPO Box 2100, Adelaide SA 5001
Country [2] 554 0
Australia
Other collaborator category [3] 555 0
Individual
Name [3] 555 0
Professor Leslie Cleland
Address [3] 555 0
Royal Adelaide Hospital, Rheumatology Unit, Frome Road, Adelaide SA 5000
Country [3] 555 0
Australia
Other collaborator category [4] 556 0
Individual
Name [4] 556 0
Professor Michael James
Address [4] 556 0
Royal Adelaide Hospital, Rheumatology Unit, Frome Road, Adelaide SA 5000
Country [4] 556 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6509 0
Southern Adelaide Health Service Human Research and Ethics Committee
Ethics committee address [1] 6509 0
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 6509 0
Australia
Date submitted for ethics approval [1] 6509 0
01/02/2009
Approval date [1] 6509 0
17/06/2010
Ethics approval number [1] 6509 0
57/10
Ethics committee name [2] 6812 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [2] 6812 0
Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Ethics committee country [2] 6812 0
Australia
Date submitted for ethics approval [2] 6812 0
05/05/2010
Approval date [2] 6812 0
03/06/2010
Ethics approval number [2] 6812 0
100515

Summary
Brief summary
The anti-inflammatory properties of fish oil are well documented. Hip fracture is common and patients suffer significant unintentional weight and muscle loss leading to poor outcomes. An inflammatory response to the injury is a plausible mechanism for the lack of response observed in these patients when provided with best practice nutrition. This study aims to reduce the weight loss suffered by hip fracture patients by prescribing an intervention of individualised nutrition support and fish oil.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29249 0
Address 29249 0
Country 29249 0
Phone 29249 0
Fax 29249 0
Email 29249 0
Contact person for public queries
Name 12496 0
Dr Michelle Miller
Address 12496 0
Department of Nutrition and Dietetics, Flinders University, GPO Box 2100, Adelaide SA 5001
Country 12496 0
Australia
Phone 12496 0
+61 8 8204 5328
Fax 12496 0
+61 8 8204 6406
Email 12496 0
michelle.miller@flinders.edu.au
Contact person for scientific queries
Name 3424 0
Dr Michelle Miller
Address 3424 0
Department of Nutrition and Dietetics, Flinders University, GPO Box 2100, Adelaide SA 5001
Country 3424 0
Australia
Phone 3424 0
+61 8 8204 5328
Fax 3424 0
+61 8 8204 6406
Email 3424 0
michelle.miller@flinders.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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