Polycystic Ovary SyndromeNCT01189669
n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
A study testing LC n-3 PUFA (fish oil) Supplement in people with Polycystic Ovary Syndrome, run by The Adelaide and Meath Hospital at 2 sites in Ireland.
Trial summary
This is a dietary intervention study designed to assess the impact of long chain (LC) n-3 polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- LC n-3 PUFA (fish oil) Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesIreland
- Study dates
- Sep 2007to Jul 2008
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
- Were between the ages of 18 and 40
Who cannot join
- Were under 18 years or greater than 40 years old,
- Were non-Caucasian
- Were pregnant, lactating or trying to conceive
- Had a body mass index (BMI) <18kg/m2 or >50kg/m2
- Had a recent illness or any chronic illness likely to influence results
- Were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents
- Were taking nutritional supplements
- Consumed greater than 2 portions of oily fish per week
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Diabetes Day Centre, The Adelaide and Meath Hospital
Dublin, Dublin, 24
Nutrigenomics Research Group, UCD
Dublin, Dublin, 4
About this study
Official title: Long Chain (LC) n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS): A Cross-over, Placebo Controlled Dietary Intervention Study
This is a dietary intervention study designed to assess the impact of long chain (LC) n-3 polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS). Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a chronic condition affecting young women of reproductive age. Long-term, safe and efficacious treatments are needed for women with this condition, and dietary therapy may have an important role in its treatment. LC n-3 PUFA have been shown to be potent biological regulators, involved in the amelioration of many of the adverse metabolic risk factors which are often present in women with PCOS. The aim of this study was to explore the impact of LC n-3 PUFA on fasting and post-prandial lipid metabolism, as well as on the hormonal profile of women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- LC n-3 PUFA (fish oil) Supplement, Placebo (olive oil) supplement
- Keywords
- PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC n-3 PUFA (fish oil) SupplementDietary supplement
Also called LC n-3 PUFA (fish oil), Placebo (PL), Wash-out (WO)
4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks
Placebo (olive oil) supplementDietary supplement
4 x 1g olive oil capsules were given daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| LC n-3 PUFA | Active comparator | Supplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks. Receives: Dietary Supplement: LC n-3 PUFA (fish oil) Supplement |
| Placebo (olive oil) supplement | Placebo comparator | 4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks. Receives: Dietary Supplement: Placebo (olive oil) supplement |
| Wash out period | No intervention | A 6 week wash out period separated the LC n-3 PUFA and the Placebo (olive oil) arms. During this period the subjects took no supplements. This arm was designed to minimise a cross-over effect. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting lipid metabolism
Measured: Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Secondary outcomes (2)
Plasma hormonal profile
Measured: Following supplementation with LCn-3PUFA or placebo for 6 weeks
Postprandial lipid metabolism
Measured: Following supplementation with LCn-3 PUFA or placebo for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startSep 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Adelaide and Meath Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Investigators
- James Gibney, Dr, Principal investigator, The Adelaide and Meath Hospital, incorporating The National Children's HospitalHelen M Roche, Prof, Principal investigator, UCD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189669
- Sponsor's protocol ID
- DDC-UCD-PCOS
- Status last verified
- Jul 2008
- First submitted
- 24 Aug 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26.
PubMed 21270384
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Chain (LC) n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS): A Cross-over, Placebo Controlled Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT01189669
- Acronym / sponsor ID
- DDC-UCD-PCOS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Adelaide and Meath HospitalUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Aug 2010 (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.
This is a dietary intervention study designed to assess the impact of long chain (LC) n-3 polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS). Considering that LC n-3 PUFA have been reported to have a beneficial affect on many of the adverse metabolic and hormonal aspects of PCOS, it was hypothesised that dietary supplementation with LC n-3 PUFA would have a beneficial therapeutic impact.
Detailed description
Polycystic ovary syndrome (PCOS) is a chronic condition affecting young women of reproductive age. Long-term, safe and efficacious treatments are needed for women with this condition, and dietary therapy may have an important role in its treatment. LC n-3 PUFA have been shown to be potent biological regulators, involved in the amelioration of many of the adverse metabolic risk factors which are often present in women with PCOS. The aim of this study was to explore the impact of LC n-3 PUFA on fasting and post-prandial lipid metabolism, as well as on the hormonal profile of women with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LC n-3 PUFA | Active comparator | Dietary Supplement: LC n-3 PUFA (fish oil) SupplementSupplementation with 4 x 1g fish oil capsules (Seven Seas, Ireland) containing 1.9g combined EPA and DHA daily for 6 weeks. |
| Placebo (olive oil) supplement | Placebo comparator | Dietary Supplement: Placebo (olive oil) supplement4 x 1g olive oil capsules (Millas Inc) were given daily for 6 weeks. |
| Wash out period | No intervention | –A 6 week wash out period separated the LC n-3 PUFA and the Placebo (olive oil) arms. During this period the subjects took no supplements. This arm was designed to minimise a cross-over effect. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
- Were between the ages of 18 and 40
Key exclusion criteria (8 listed)
- Were under 18 years or greater than 40 years old,
- Were non-Caucasian
- Were pregnant, lactating or trying to conceive
- Had a body mass index (BMI) <18kg/m2 or >50kg/m2
- Had a recent illness or any chronic illness likely to influence results
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 |
|---|---|---|
| LC n-3 PUFA (fish oil) SupplementAlso: LC n-3 PUFA (fish oil), Placebo (PL), Wash-out (WO)4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks | Dietary supplement | LC n-3 PUFA |
| Placebo (olive oil) supplement4 x 1g olive oil capsules were given daily for 6 weeks | Dietary supplement | Placebo (olive oil) supplement |
Primary outcome
Fasting lipid metabolism
Time frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks
2 secondary outcomes
Plasma hormonal profile
Time frame: Following supplementation with LCn-3PUFA or placebo for 6 weeks
Postprandial lipid metabolism
Time frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks
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 13 Sep 2010.
- Derived from this study: PubMed 21270384Phelan N, O'Connor A, Kyaw Tun T, Correia N, Boran G, Roche HM, Gibney J. Hormonal and metabolic effects of polyunsaturated fatty acids in young women with polycystic ovary syndrome: results from a cross-sectional analysis and a randomized, placebo-controlled, crossover trial. Am J Clin Nutr. 2011 Mar;93(3):652-62. doi: 10.3945/ajcn.110.005538. Epub 2011 Jan 26.
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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.
James Gibney, Dr principal investigator
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Helen M Roche, Prof principal investigator
UCD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LC n-3 PUFA (fish oil) Supplement in people with Polycystic Ovary Syndrome, run by The Adelaide and Meath Hospital at 2 sites in Ireland.
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 2 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 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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.
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?
Fasting lipid metabolism (time frame: Following supplementation with LCn-3 PUFA or placebo for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01189669, which also lists 1 linked publication.
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 13 Sep 2010.