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
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
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
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
[email protected]
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
[email protected]

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
No additional documents have been identified.