Hot FlashesNCT00599456
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
A study testing Omega 3 fatty acid vitamins in people with Hot Flashes and Menopause, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Hot flashes can be a disturbing symptom of menopause. Prescription medications are commonly used for symptom relief. Several non-prescription therapies are under investigation. This study will examine the use of omega-3 (fish oil) supplements to see if it helps relieve hot flashes and therefore improve the quality of… Read more about this study
- Who is it for?
- Ages Up to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Menopause
- What is being tested?
- Omega 3 fatty acid vitamins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2009
- 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 Up to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Post menopausal females (no periods for over 6 months)
- Documented Serum FSH level>20
- Positive urine FSH test
- Hot flashes, on average five a day
- A 2 week pre study washout period of exclusion criteria
Who cannot join
- No EPT/ET
- OTC supplements: ex; soy, black cohosh, flax, bellergal, primrose oil, vitamin E, red clover
- Excessive smoking > 1ppd
- Anti seizure medications
- Clonidine
- Effexor
- More than 2 servings of fish per week
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Systems
Newark, Delaware, 19718
About this study
Official title: A Placebo Controlled Double Blinded Prospective Study to Investigate the Usefulness of Omega 3 Fatty Acids in the Relief of Vasomotor Symptoms of Menopausal Women
Hot flashes can be a disturbing symptom of menopause. Prescription medications are commonly used for symptom relief. Several non-prescription therapies are under investigation. This study will examine the use of omega-3 (fish oil) supplements to see if it helps relieve hot flashes and therefore improve the quality of life.
Study Hypotheses:
Menopausal women who take Omega 3 vitamins(fish oils)will show improvement in the severity of their hot flashes.In addition women who take Omega 3 supplements will show improvement in their lipid profiles.
Read the detailed description
This study requires you to have blood drawn twice, record your hot flashes for a total of 3 weeks, and to take a product every day for 12 weeks. It will also entail 4 visits and up to 4 telephone contacts. The information you provide will be maintained in a database accessible only to the primary investigator and research team. You will be assigned a code number for your blood work and all other information. The key to this code will be maintained in this database.
Overall 60-100 women will be recruited for this study locally. During the course of the study you will get overall two blood draws amounting to up to a teaspoon for measurement of your cholesterol and fat levels.
This project consists of three phases.
Phase I
We will ask you questions about your medical history and your health. You will then be asked to provide a urine sample which will be used to confirm your menopausal status with a FSH level. You will be requested to keep a record of your hot flashes for one week using a symptom diary. Upon completion of the diary, you will return to the study site. If you qualify for participation, you will have blood work done to measure your cholesterol and other fat levels through a lipid panel. You will be provided with these results free of charge at the conclusion of the study.
Phase 2
You will receive the study medication. Half of the participants will receive the actual product we are investigating and half will receive a placebo (inactive/dummy pill). Neither you nor the investigators will not know which one you are given until the end of the study. During the 4th and 12th weeks, you will be asked to keep a diary (similar to the first one) of your hot flashes.
Phase 3
At the end of the 12 week study period, you will return to the study center. The second blood draw will be done to monitor any changes. This will conclude your participation. You will be sent a copy of your cholesterol profiles and FSH levels approximately 2 weeks after you complete the study.
- Conditions
- Hot Flashes, Menopause
- Being tested
- Omega 3 fatty acid vitamins, Placebo capsules
- Keywords
- Hot flashes, Menopause, Omega 3 fatty Acids
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acid vitaminsDietary supplement
Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months
Placebo capsulesDietary supplement
Placebo capsules,2 capsules, by mouth, daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Omega 3 vitamin supplements Receives: Dietary Supplement: Omega 3 fatty acid vitamins |
| 2 | Placebo comparator | Placebo capsule Receives: Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease in the severity in hot flashes.
Measured: 3 months
Secondary outcomes (1)
Improvement in lipid profile
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parastoo Farhady, MD, Principal investigator, Chrisitiana care Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599456
- Sponsor's protocol ID
- 27103
- Status last verified
- May 2017
- First submitted
- 11 Jan 2008
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Double Blinded Prospective Study to Investigate the Usefulness of Omega 3 Fatty Acids in the Relief of Vasomotor Symptoms of Menopausal Women
- ClinicalTrials.gov ID
- NCT00599456
- Acronym / sponsor ID
- 27103
- Conditions
- Hot Flashes, Menopause
- Keywords
- Hot flashes, Menopause, Omega 3 fatty Acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Jan 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.
Hot flashes can be a disturbing symptom of menopause. Prescription medications are commonly used for symptom relief. Several non-prescription therapies are under investigation. This study will examine the use of omega-3 (fish oil) supplements to see if it helps relieve hot flashes and therefore improve the quality of life.
Study Hypotheses:
Menopausal women who take Omega 3 vitamins(fish oils)will show improvement in the severity of their hot flashes.In addition women who take Omega 3 supplements will show improvement in their lipid profiles.
Detailed description
This study requires you to have blood drawn twice, record your hot flashes for a total of 3 weeks, and to take a product every day for 12 weeks. It will also entail 4 visits and up to 4 telephone contacts. The information you provide will be maintained in a database accessible only to the primary investigator and research team. You will be assigned a code number for your blood work and all other information. The key to this code will be maintained in this database.
Overall 60-100 women will be recruited for this study locally. During the course of the study you will get overall two blood draws amounting to up to a teaspoon for measurement of your cholesterol and fat levels.
This project consists of three phases.
Phase I
We will ask you questions about your medical history and your health. You will then be asked to provide a urine sample which will be used to confirm your menopausal status with a FSH level. You will be requested to keep a record of your hot flashes for one week using a symptom diary. Upon completion of the diary, you will return to the study site. If you qualify for participation, you will have blood work done to measure your cholesterol and other fat levels through a lipid panel. You will be provided with these results free of charge at the conclusion of the study.
Phase 2
You will receive the study medication. Half of the participants will receive the actual product we are investigating and half will receive a placebo (inactive/dummy pill). Neither you nor the investigators will not know which one you are given until the end of the study. During the 4th and 12th weeks, you will be asked to keep a diary (similar to the first one) of your hot flashes.
Phase 3
At the end of the 12 week study period, you will return to the study center. The second blood draw will be done to monitor any changes. This will conclude your participation. You will be sent a copy of your cholesterol profiles and FSH levels approximately 2 weeks after you complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Omega 3 fatty acid vitaminsOmega 3 vitamin supplements |
| 2 | Placebo comparator | Dietary Supplement: Placebo capsulesPlacebo capsule |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Post menopausal females (no periods for over 6 months)
- Documented Serum FSH level>20
- Positive urine FSH test
- Hot flashes, on average five a day
- A 2 week pre study washout period of exclusion criteria
Key exclusion criteria (7 listed)
- No EPT/ET
- OTC supplements: ex; soy, black cohosh, flax, bellergal, primrose oil, vitamin E, red clover
- Excessive smoking > 1ppd
- Anti seizure medications
- Clonidine
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 |
|---|---|---|
| Omega 3 fatty acid vitaminsOmega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months | Dietary supplement | 1 |
| Placebo capsulesPlacebo capsules,2 capsules, by mouth, daily for 3 months | Dietary supplement | 2 |
Primary outcome
The decrease in the severity in hot flashes.
Time frame: 3 months
1 secondary outcome
Improvement in lipid profile
Time frame: 3 months
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 10 May 2017.
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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.
Parastoo Farhady, MD principal investigator
Chrisitiana care Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 fatty acid vitamins in people with Hot Flashes and Menopause, run by Christiana Care Health Services at 1 site in United States.
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 7 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 10 May 2017. 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 United States. 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?
The decrease in the severity in hot flashes. (time frame: 3 months). 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 10 May 2017.