Hot Flashes and Omega 3 (BOOM3)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Vivatech
Sponsor:
Collaborator:
Centre d'Investigation Clinique de Grenoble CIC1406
Information provided by (Responsible Party):
Vivatech
ClinicalTrials.gov Identifier:
NCT02062528
First received: February 12, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Vivatech:

Primary Outcome Measures:
  • hot flashes frequency [ Time Frame: 1 to 8 week ] [ Designated as safety issue: No ]
    ANOVA by repeated measures


Secondary Outcome Measures:
  • hot flashes frequency difference [ Time Frame: 4 week and 8 week ] [ Designated as safety issue: No ]
    difference betwwen week8 and week4 and week0

  • diurnal hot flashes [ Time Frame: week 1 to 8 ] [ Designated as safety issue: No ]
    ANOVA and difference

  • night hot flashes [ Time Frame: week 1 to 8 ] [ Designated as safety issue: No ]
    ANOVA and difference

  • vasomotors disorders [ Time Frame: week 1 to week 8 ] [ Designated as safety issue: No ]
    ANOVA and differences

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: week 0 and week 8 ] [ Designated as safety issue: No ]
    sleep quality

  • HFRDIS [ Time Frame: week 0 and week 8 ] [ Designated as safety issue: No ]
    quality of life

  • The Menopause-Specific Quality of Life (MENQOL) [ Time Frame: week 0 and week 8 ] [ Designated as safety issue: No ]
    quality of life

  • Weight [ Time Frame: week 0 and week 8 ] [ Designated as safety issue: No ]
  • fatty acids dosage [ Time Frame: week 0 and week 8 ] [ Designated as safety issue: No ]
    fatty acids dosage

  • number of adverse events [ Time Frame: week 0 to week 8 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 136
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062528

Contacts
Contact: Adeline PARIS, PharmD-PhD 04-76-76-73-83 AParis@chu-grenoble.fr
Contact: Béatrice SPILUTTINI, PhD BSPILUTTINI@vivatech.fr

Locations
France
Centre d'investigation clinique CIC1406 Not yet recruiting
GRENOBLE cedex9, France, 38043
Contact: PARIS Adeline    33476767383    AParis@chu-grenoble.fr   
Principal Investigator: Jean-Luc CRACOWSKI, MD-PhD         
Sub-Investigator: Claire CRACOWSKI, MD         
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

No publications provided

Responsible Party: Vivatech
ClinicalTrials.gov Identifier: NCT02062528     History of Changes
Other Study ID Numbers: DCIC 13 15
Study First Received: February 12, 2014
Last Updated: February 12, 2014
Health Authority: France: ANSM - French Health Products Safety Agency

Keywords provided by Vivatech:
EPA

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014