Hot Flashes and Omega 3 (BOOM3)

December 8, 2015 updated by: Vivatech

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • GRENOBLE cedex9, France, 38043
        • Centre d'investigation clinique CIC1406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • groupe actif
Placebo Comparator: placebo
3 capsules each day during 8 weeks
Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hot flashes frequency
Time Frame: 1 to 8 week
ANOVA by repeated measures
1 to 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hot flashes frequency difference
Time Frame: 4 week and 8 week
difference betwwen week8 and week4 and week0
4 week and 8 week
diurnal hot flashes
Time Frame: week 1 to 8
ANOVA and difference
week 1 to 8
night hot flashes
Time Frame: week 1 to 8
ANOVA and difference
week 1 to 8
vasomotors disorders
Time Frame: week 1 to week 8
ANOVA and differences
week 1 to week 8
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: week 0 and week 8
sleep quality
week 0 and week 8
HFRDIS
Time Frame: week 0 and week 8
quality of life
week 0 and week 8
The Menopause-Specific Quality of Life (MENQOL)
Time Frame: week 0 and week 8
quality of life
week 0 and week 8
Weight
Time Frame: week 0 and week 8
week 0 and week 8
fatty acids dosage
Time Frame: week 0 and week 8
fatty acids dosage
week 0 and week 8
number of adverse events
Time Frame: week 0 to week 8
week 0 to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivatech

Collaborators

Centre d'Investigation Clinique de Grenoble CIC1406

Investigators

  • Principal Investigator: Jean-Luc CRACOWSKI, MD-PhD, Centre d'investigation clinique CIC1406

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 13 15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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