Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00620529




Registration number
NCT00620529
Ethics application status
Date submitted
11/02/2008
Date registered
21/02/2008
Date last updated
2/02/2010

Titles & IDs
Public title
The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome
Scientific title
A Clinical Trial to Measure the Effect of DHA-enriched Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat Content in the Polycystic Ovary Syndrome
Secondary ID [1] 0 0
EC 2008/049
Universal Trial Number (UTN)
Trial acronym
fops
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ocean Nutrition 2050
Treatment: Other - Olive oil capsules

Experimental: 1 - 20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day.

Placebo comparator: 2 - olive oil capsules


Treatment: Other: Ocean Nutrition 2050
1000mg capsules, 4 capsules/day for 8 weeks

Treatment: Other: Olive oil capsules
Olive oil capsules, 4 per day for 8 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24 hour ambulatory systolic blood pressure
Timepoint [1] 0 0
week 8 and week 24
Secondary outcome [1] 0 0
24 hour heart rate variability
Timepoint [1] 0 0
week 8 and week 24
Secondary outcome [2] 0 0
liver fat content (MRI)
Timepoint [2] 0 0
week 8 and week 24

Eligibility
Key inclusion criteria
* Overweight/obese women with PCOS as per 1990 NIH criteria (see below)
* Non-smokers
* Age>18 years, premenopausal
* Acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia
* Acceptable to be taking the oral contraceptive pill
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncontrolled hypertension (BP>160/100mmHg)
* Known co-morbidities including liver or renal disease
* Already taking fish oil supplements
* Other intercurrent illness (major surgery, CV event)
* Smokers
* Alcohol intake >20g/day
* Pregnancy
* Any metallic implant (contraindication for MRI).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
School of Medicine and Pharmacology, Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Keogh Institute for Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Perth Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in women with PCOS. The purpose of this study therefore is to examine the effects of fish oils on blood pressure, heart rate variability and liver fat content in obese women with the polycystic ovary syndrome.
Trial website
https://clinicaltrials.gov/study/NCT00620529
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrea J Cussons, MBBS
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00620529