Hot Flashes and Omega 3

N/ACompletedNCT02062528

Vivatech136 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Hot Flashes Fatty Acids Menopause

Interventions

omega-3 fatty acidsDIETARY_SUPPLEMENT

highly dosed in EPA

placeboDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Centre d'investigation clinique CIC1406

Grenoble Cedex9, France

Outcomes

Primary Outcomes

hot flashes frequency

ANOVA by repeated measures

Time frame: 1 to 8 week

Secondary Outcomes

hot flashes frequency difference

difference betwwen week8 and week4 and week0

Time frame: 4 week and 8 week

diurnal hot flashes

ANOVA and difference

Time frame: week 1 to 8

night hot flashes

ANOVA and difference

Time frame: week 1 to 8

vasomotors disorders

ANOVA and differences

Time frame: week 1 to week 8

Pittsburgh Sleep Quality Index (PSQI)

sleep quality

Time frame: week 0 and week 8

HFRDIS

quality of life

Time frame: week 0 and week 8

The Menopause-Specific Quality of Life (MENQOL)

quality of life

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

Data from ClinicalTrials.gov

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