Polycystic Ovary SyndromePhase 4fopsNCT00620529
The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome
A Phase 4 study testing Ocean Nutrition 2050 and Olive oil capsules in people with Polycystic Ovary Syndrome, run by Keogh Institute for Medical Research at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Ocean Nutrition 2050 and Olive oil capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2008to Feb 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Medicine and Pharmacology, Royal Perth Hospital
Perth, Western Australia, 6000
About this study
Official 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
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.
Read the detailed description
The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We hypothesise that fish oils will have a beneficial effect on these endpoints and other cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils on the above parameters compared with placebo (olive oil). Subjects with PCOS who have participated in previous studies with this research group will be approached for recruitment, as will eligible subjects within the endocrine clinics of the chief and co-investigators.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Ocean Nutrition 2050, Olive oil capsules
- Keywords
- polycystic ovary syndrome, cardiovascular risk, metabolism, blood pressure, liver fat, heart rate variability
- Medical subject headings
- Polycystic Ovary Syndrome, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocean Nutrition 2050Dietary supplement
Also called Code name: 2050
1000mg capsules, 4 capsules/day for 8 weeks
Olive oil capsulesDietary supplement
Olive oil capsules, 4 per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day. Receives: Dietary Supplement: Ocean Nutrition 2050 |
| 2 | Placebo comparator | olive oil capsules Receives: Dietary Supplement: Olive oil capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour ambulatory systolic blood pressure
Measured: week 8 and week 24
Secondary outcomes (2)
24 hour heart rate variability
Measured: week 8 and week 24
liver fat content (MRI)
Measured: week 8 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keogh Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Perth Hospital
- Investigators
- Andrea J Cussons, MBBS, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620529
- Sponsor's protocol ID
- EC 2008/049
- Acronym
- fops
- Status last verified
- Jan 2010
- First submitted
- 11 Feb 2008
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00620529
- Acronym / sponsor ID
- fops / EC 2008/049
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, cardiovascular risk, metabolism, blood pressure, liver fat, heart rate variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Keogh Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- Royal Perth Hospital
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We hypothesise that fish oils will have a beneficial effect on these endpoints and other cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils on the above parameters compared with placebo (olive oil). Subjects with PCOS who have participated in previous studies with this research group will be approached for recruitment, as will eligible subjects within the endocrine clinics of the chief and co-investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Ocean Nutrition 205020/50 fish oil, 1000mg capsules, Ocean Nutrition 2050,4g/day. |
| 2 | Placebo comparator | Dietary Supplement: Olive oil capsulesolive oil capsules |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocean Nutrition 2050Also: Code name: 20501000mg capsules, 4 capsules/day for 8 weeks | Dietary supplement | 1 |
| Olive oil capsulesOlive oil capsules, 4 per day for 8 weeks | Dietary supplement | 2 |
Primary outcome
24 hour ambulatory systolic blood pressure
Time frame: week 8 and week 24
2 secondary outcomes
24 hour heart rate variability
Time frame: week 8 and week 24
liver fat content (MRI)
Time frame: week 8 and week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
Related trials for Polycystic Ovary Syndrome
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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea J Cussons, MBBS principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ocean Nutrition 2050 and Olive oil capsules in people with Polycystic Ovary Syndrome, run by Keogh Institute for Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour ambulatory systolic blood pressure (time frame: week 8 and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010.