Hot Flashes and Omega 3

NCT ID: NCT02062528

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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Conditions

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Hot Flashes Fatty Acids Menopause

Keywords

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EPA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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omega-3 fatty acids

3 capsules each day during 8 weeks

Group Type EXPERIMENTAL

omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

highly dosed in EPA

placebo

3 capsules each day during 8 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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omega-3 fatty acids

highly dosed in EPA

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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groupe actif

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre d'Investigation Clinique de Grenoble CIC1406

UNKNOWN

Sponsor Role collaborator

Vivatech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc CRACOWSKI, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Centre d'investigation clinique CIC1406

Locations

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Centre d'investigation clinique CIC1406

Grenoble Cedex9, , France

Site Status

Countries

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France

Other Identifiers

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DCIC 13 15

Identifier Type: -

Identifier Source: org_study_id