Hot Flashes and Omega 3

Not Applicable

Completed

• Conditions: Hot Flashes; Fatty Acids; Menopause
• Interventions: Dietary Supplement: placebo; Dietary Supplement: omega-3 fatty acids

• Registration Number: NCT02062528
• Lead Sponsor: Vivatech

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Study Start: 2014-03
• Primary Completion: 2015-05
• Study Completion: 2015-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	3 capsules each day during 8 weeks
omega-3 fatty acids	omega-3 fatty acids	3 capsules each day during 8 weeks

Primary Outcome Measures

Name	Time	Method
hot flashes frequency	1 to 8 week	ANOVA by repeated measures

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre d'investigation clinique CIC1406; 🇫🇷 GRENOBLE cedex9, France