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Hot Flashes and Omega 3 (BOOM3)

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ClinicalTrials.gov Identifier: NCT02062528
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.

Condition or disease Intervention/treatment
Hot Flashes Fatty Acids Menopause Dietary Supplement: omega-3 fatty acids Dietary Supplement: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2014
Primary Completion Date : May 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: omega-3 fatty acids
3 capsules each day during 8 weeks
Dietary Supplement: omega-3 fatty acids
highly dosed in EPA
Other Name: groupe actif
Placebo Comparator: placebo
3 capsules each day during 8 weeks
Dietary Supplement: placebo


Outcome Measures

Primary Outcome Measures :
  1. hot flashes frequency [ Time Frame: 1 to 8 week ]
    ANOVA by repeated measures


Secondary Outcome Measures :
  1. hot flashes frequency difference [ Time Frame: 4 week and 8 week ]
    difference betwwen week8 and week4 and week0

  2. diurnal hot flashes [ Time Frame: week 1 to 8 ]
    ANOVA and difference

  3. night hot flashes [ Time Frame: week 1 to 8 ]
    ANOVA and difference

  4. vasomotors disorders [ Time Frame: week 1 to week 8 ]
    ANOVA and differences

  5. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: week 0 and week 8 ]
    sleep quality

  6. HFRDIS [ Time Frame: week 0 and week 8 ]
    quality of life

  7. The Menopause-Specific Quality of Life (MENQOL) [ Time Frame: week 0 and week 8 ]
    quality of life

  8. Weight [ Time Frame: week 0 and week 8 ]
  9. fatty acids dosage [ Time Frame: week 0 and week 8 ]
    fatty acids dosage

  10. number of adverse events [ Time Frame: week 0 to week 8 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • menopause or peri menopause
  • complaining of hot flashes
  • social security affiliation
  • informed consent form signed

Exclusion Criteria:

  • 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062528


Locations
France
Centre d'investigation clinique CIC1406
GRENOBLE cedex9, France, 38043
Sponsors and Collaborators
Vivatech
Centre d'Investigation Clinique de Grenoble CIC1406
Investigators
Principal Investigator: Jean-Luc CRACOWSKI, MD-PhD Centre d'investigation clinique CIC1406
More Information

Responsible Party: Vivatech
ClinicalTrials.gov Identifier: NCT02062528     History of Changes
Other Study ID Numbers: DCIC 13 15
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Vivatech:
EPA

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms