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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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00620529