Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000398000
Ethics application status
Approved
Date submitted
7/05/2010
Date registered
18/05/2010
Date last updated
17/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of Omega 3 fatty acids on osmosensation and thirst signaling
Scientific title
Influence of Omega 3 fatty acids on osmosensation and thirst signaling in ambulatory patients aged 65-85 to improve thirst sensation, voluntary fluid intake and improve quality of life in elderly subjects.
Secondary ID [1] 251786 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Improving dehydration in elderly by supplementation of Omega 3 fatty acids 257298 0
Improving thirst sensation by supplementation of Omega 3 fatty acids 257299 0
Improving quality of life by supplementation of Omega 3 fatty acids 257300 0
Fluid intake 257384 0
Condition category
Condition code
Public Health 257448 257448 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stage1 (Questionnaire survey) : A self–structured questionnaire survey (assessment for eligibility to participate) and mini-mental state examination (MMSE- psychological assessment for cognitive impairment) will be conducted among all elderly residents from aged care group facilities in Victoria, (aged 65-85y, inclusive), to screen them for stage 2 and 3 studies. Each participant will be provided an information sheet and consent will be obtained (subjected to approval from Victoria University Human Ethics Committee).
Stage 2 (Prospective study- 5 days)
This phase study is designed to identify the subjects who are prone to dehydration, thirst deficit, low erythrocyte omega 3 fatty acid levels and whether it is possible accept omega 3 fatty acid supplementation. The fluid intake of the participants in stage 2 will be recorded for 5 days inclusive of a week end. A blood and urine sample will be collected for biochemical analysis. Other clinical assessments include blood pressure and heart rate (both standing and lying position), Body mass index calculation, presence of dry tongue, tongue furrows or dry oral membrane (physical examination) and thirst ratings. A sensory screening test will be conducted to evaluate the participant’s level of acceptance of the fish oil or the placebo oil.
Stage 3:The recruitment will be based on subjects found to exhibit dehydration and thirst deficit (from prospective study). In this single blinded study, the participants will be randomly allocated based on age, sex, body weight to
Intervention
(a) Intervention group: 3 months consumption of omega 3 fatty acids (5 ml fish oil once a day(Melrose, Norwegian fish oil; which contains 815 mg of Eicosapentaenoic and 540 mg of Docosahexaenoic) will be given to intervention group
or

(b) Control Placebo group: 3 months consumption of 5 ml of cold pressed soya bean oil, both floated on fruit juice (lemon) once a day will be given to placebo participants . Both cohorts will be given additional 5 ml of fruit juice to rinse the mouth.
Intervention code [1] 256431 0
Prevention
Comparator / control treatment
Control placebo group
Control group
Placebo

Outcomes
Primary outcome [1] 258437 0
Voluntary fluid intake with omega 3 fatty acid supplementation

Tool:Graduated bottled water will be provided to participants to monitor the daily volume of water consumption. This will be recorded in a nutrition diary in addition to all other fluids like tea, coffee, soup or juice etc for both intervention and placebo cohorts.
Timepoint [1] 258437 0
Thrice a week throughout for the entire study period of 3 months
Primary outcome [2] 258438 0
Improving thirst sensation

Tool: Measured by a scored visual analogue scale, where the participants will be asked to mark a scale between 0-5 for both intervention and placebo cohorts. The thirst rating scale comprises of: 0 score- not at all thirsty, 1-slightly thirsty, 2-moderately thirsty, 3-strongly or very thirsty and 4-extremely thirsty and 5- severve thirst.
Timepoint [2] 258438 0
Measuring the thirst rates at the base line, in end of month 1, end of month 2 and end of month 3 at the blood sampling time and at 2 instance of thirst challenge with salt meal/drink for both cohorts.
Secondary outcome [1] 264221 0
Quality of life change with omega 3 fatty acid supplementation

Tools: Quality of life will assessment by SF-36 assessment tool for both cohorts. at the start of the trial ( month 1) and at the end of 3 month trial period for both cohorts.
Timepoint [1] 264221 0
Base line assessment of quality of life at the start of the trial (month 1) and at the end of 3 month trial period for both cohorts.

Eligibility
Key inclusion criteria
The participants who meet the following criteria will be included in the study
Age between 65 - 85y (inclusive) of both sex (ambulatory subjects).
Provide an informed consent
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mandatory exclusion criteria
Subjects who are included in any other clinical trials.
Abnormal kidney function, liver function and incomplete bladder control (enuresis).
Subjects on anticoagulant and diuretic medications.
Subjects with cardiac and/or chronic inflammatory conditions.
Subjects with hemorrhagic stroke and high diabetics conditions.
Allergy to fish products and currently on fish oil or flax seed supplements.
Subjects on fluid / salt restriction diet and severe cognitive impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Stage1 (Questionnaire survey) : A self–structured questionnaire survey (assessment for eligibility to participate) and mini-mental state examination (MMSE- psychological assessment for cognitive impairment).
Stage 2 (Prospective study- 5 days)
This phase study is designed to identify the subjects who are prone to dehydration, thirst deficit, low erythrocyte omega 3 fatty acid levels and whether it is possible accept omega 3 fatty acid supplementation
Stage 3 (Pilot clinical trial)
The recruitment will be based on subjects found to exhibit dehydration and thirst deficit (from stage 2).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All the subjects will be randomized based on sex, Age and body weight by using procedures such as coin-tossing. The participants with similar age group (65-80) and body weights (60-80 kg) and equal number of males and females will be allocated for randomisation . The coin will be tossed and all the heads will be intervention group and tails will be in the control placebo group till all the participants are equally divided in two cohort groups. Previous treatment is used for the stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2887 0
3011

Funding & Sponsors
Funding source category [1] 256921 0
University
Name [1] 256921 0
Victoria University, Melbourne
Country [1] 256921 0
Australia
Primary sponsor type
University
Name
Victoria University, Melbourne
Address
School of Biomedical and Health Sciences
Victoria University, St Albans Campus,
Building 6, McKechnie st, VIC 3021
Melbourne, Australia
Country
Australia
Secondary sponsor category [1] 256190 0
Individual
Name [1] 256190 0
Anitha Dudhani and Dr. Michael Mathai
Address [1] 256190 0
School of Biomedical and Health Sciences
Victoria University, St Albans Campus,
Building 6, McKechnie st, VIC 3021
Melbourne, Australia
Country [1] 256190 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258927 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 258927 0
Ethics committee country [1] 258927 0
Australia
Date submitted for ethics approval [1] 258927 0
26/05/2010
Approval date [1] 258927 0
29/09/2010
Ethics approval number [1] 258927 0
HRETH 10/97

Summary
Brief summary
Aim: To conduct a prospective trial in a cohort of elderly people to discover the prevalence of dehydration and any association with Omega 3 fatty acid deficiency. This will be followed by a pilot clinical trial aiming to test if 3 month nutritional supplementation with Omega 3 fatty acid may improve thirst sensation, voluntary fluid intake and improve quality of life in comparison with elderly on placebo control.

Hypothesis
We hypothesise that, there is a positive correlation between prevalence of dehydration and omega 3 fatty acid deficiency in the elderly and supplementation with omega 3 fatty acid will reduce the occurrence of dehydration and improve Quality of life
Factors that predispose elderly to dehydration
1. Changes to kidney function and insufficient sensation of thirst.
2. Hormonal changes; normal /increased production of vasopressin, increased response to osmotic stimulation and decreased nocturnal secretions. Atrial natriuretic peptide (ANP) increases secretions with increased stimulation, decreased renin activity and aldosterone production.
3. Neurological impairments altering the hypothalamus and pituitary gland, which affect sensation of thirst.

4. Medication (for example, diuretics and laxatives).

5. Chronic illness, communication issues cognitive difficulties and limited mobility.

6. Not drinking enough water to avoid occurrence of incontinence.
7. Fuid loss due to diarrhoea or vomiting and not compensating for loss.
Outcome
Improved thirst sensation, voluntary fluid intake and improve quality of life in elderly subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31132 0
Address 31132 0
Country 31132 0
Phone 31132 0
Fax 31132 0
Email 31132 0
Contact person for public queries
Name 14379 0
Anitha Dudhani
Address 14379 0
School of Biomedical and Health Sciences
Victoria University, St Albans Campus,
Building 6, McKechnie st, VIC 3021
Melbourne, Australia
Country 14379 0
Australia
Phone 14379 0
+610431586077
Fax 14379 0
Email 14379 0
[email protected]
Contact person for scientific queries
Name 5307 0
Dr. Michael Mathai
Address 5307 0
School of Biomedical and Health Sciences
Victoria University, St Albans Campus,
Building 6, McKechnie st, VIC 3021
Melbourne, Australia
Country 5307 0
Australia
Phone 5307 0
+61 3 9919 2211
Fax 5307 0
Email 5307 0
michael.mathai@ vu.edu.au.

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No Supporting Document Provided



Results publications and other study-related documents

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