Hot FlashesBOOM3NCT02062528
Hot Flashes and Omega 3
A study testing omega-3 fatty acids in people with Hot Flashes and Fatty Acids, run by Vivatech at 1 site in France.
Trial summary
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Fatty Acids, Menopause
- What is being tested?
- omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Jul 2015
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- menopause or peri menopause
- complaining of hot flashes
- social security affiliation
- informed consent form signed
Who cannot join
- primary pathology which can lead to hot flashes
- allergy to omega-3 fatty acids
- allergy to sea products
- High consumption of fat fish or produced by the sea
- iatrogenic hot flashes
- actual omega-3 fatty acids consumption or in the 3 last months.
- consumption of drug or other products for hot flashes in the last month
- protected persons (L1121-5 to L1121-8 of French Public health code)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.
- Conditions
- Hot Flashes, Fatty Acids, Menopause
- Being tested
- omega-3 fatty acids, placebo
- Keywords
- EPA
- 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 acidsDietary supplement
Also called groupe actif
highly dosed in EPA
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| omega-3 fatty acids | Experimental | 3 capsules each day during 8 weeks Receives: Dietary Supplement: omega-3 fatty acids |
| placebo | Placebo comparator | 3 capsules each day during 8 weeks Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
hot flashes frequency
ANOVA by repeated measures
Measured: 1 to 8 week
Secondary outcomes (10)
hot flashes frequency difference
difference betwwen week8 and week4 and week0
Measured: 4 week and 8 week
diurnal hot flashes
ANOVA and difference
Measured: week 1 to 8
night hot flashes
ANOVA and difference
Measured: week 1 to 8
vasomotors disorders
ANOVA and differences
Measured: week 1 to week 8
Pittsburgh Sleep Quality Index (PSQI)
sleep quality
Measured: week 0 and week 8
HFRDIS
quality of life
Measured: week 0 and week 8
The Menopause-Specific Quality of Life (MENQOL)
quality of life
Measured: week 0 and week 8
Weight
Measured: week 0 and week 8
fatty acids dosage
fatty acids dosage
Measured: week 0 and week 8
number of adverse events
Measured: week 0 to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionJul 2015
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivatech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre d'Investigation Clinique de Grenoble CIC1406
- Responsible party
- Sponsor
- Investigators
- Jean-Luc CRACOWSKI, MD-PhD, Principal investigator, Centre d'investigation clinique CIC1406
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062528
- Sponsor's protocol ID
- DCIC 13 15
- Acronym
- BOOM3
- Status last verified
- Dec 2015
- First submitted
- 12 Feb 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo
- ClinicalTrials.gov ID
- NCT02062528
- Acronym / sponsor ID
- BOOM3 / DCIC 13 15
- Conditions
- Hot Flashes, Fatty Acids, Menopause
- Keywords
- EPA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- VivatechIndustry (pharma, biotech, devices)
- Collaborators
- Centre d'Investigation Clinique de Grenoble CIC1406
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Feb 2014 (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.
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 fatty acids | Experimental | Dietary Supplement: omega-3 fatty acids3 capsules each day during 8 weeks |
| placebo | Placebo comparator | Dietary Supplement: placebo3 capsules each day during 8 weeks |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- menopause or peri menopause
- complaining of hot flashes
- social security affiliation
- informed consent form signed
Key exclusion criteria (8 listed)
- primary pathology which can lead to hot flashes
- allergy to omega-3 fatty acids
- allergy to sea products
- High consumption of fat fish or produced by the sea
- iatrogenic hot flashes
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 acidsAlso: groupe actifhighly dosed in EPA | Dietary supplement | omega-3 fatty acids |
| placebo | Dietary supplement | placebo |
Primary outcome
hot flashes frequency
Time frame: 1 to 8 week
ANOVA by repeated measures
10 secondary outcomes
hot flashes frequency difference
Time frame: 4 week and 8 week
diurnal hot flashes
Time frame: week 1 to 8
night hot flashes
Time frame: week 1 to 8
vasomotors disorders
Time frame: week 1 to week 8
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week 0 and week 8
HFRDIS
Time frame: week 0 and week 8
The Menopause-Specific Quality of Life (MENQOL)
Time frame: week 0 and week 8
Weight
Time frame: week 0 and week 8
fatty acids dosage
Time frame: week 0 and week 8
number of adverse events
Time frame: week 0 to week 8
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 9 Dec 2015.
Related trials for Hot Flashes
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Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Menopause, Menopausal Vasomotor Symptoms
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Self-Management Box on Hot Flash in Postmenopausal Women
Postmenopausal Flushing, Postmenopausal Symptoms
Recruiting
Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause
Perimenopause, Postmenopause
RecruitingPhase 2
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Vasomotor Symptoms
RecruitingPhase 4
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
Obesity, Menopause Hot Flashes
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.
Jean-Luc CRACOWSKI, MD-PhD principal investigator
Centre d'investigation clinique CIC1406
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 acids in people with Hot Flashes and Fatty Acids, run by Vivatech at 1 site in France.
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 4 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 9 Dec 2015. 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 France. 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?
hot flashes frequency (time frame: 1 to 8 week). 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 9 Dec 2015.