Hot Flashes and Omega 3

Menopause Clinical Trial

— BOOM3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062528
• Other study ID #: DCIC 13 15
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: December 8, 2015
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Vivatech
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM - French Health Products Safety Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Acids
• Hot Flashes
• Menopause

Intervention

Dietary Supplement:
• omega-3 fatty acids
highly dosed in EPA
• placebo

Locations

Country	Name	City	State
France	Centre d'investigation clinique CIC1406	GRENOBLE cedex9

Sponsors (2)

Lead Sponsor	Collaborator
Vivatech	Centre d'Investigation Clinique de Grenoble CIC1406

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hot flashes frequency	ANOVA by repeated measures	1 to 8 week	No
Secondary	hot flashes frequency difference	difference betwwen week8 and week4 and week0	4 week and 8 week	No
Secondary	diurnal hot flashes	ANOVA and difference	week 1 to 8	No
Secondary	night hot flashes	ANOVA and difference	week 1 to 8	No
Secondary	vasomotors disorders	ANOVA and differences	week 1 to week 8	No
Secondary	Pittsburgh Sleep Quality Index (PSQI)	sleep quality	week 0 and week 8	No
Secondary	HFRDIS	quality of life	week 0 and week 8	No
Secondary	The Menopause-Specific Quality of Life (MENQOL)	quality of life	week 0 and week 8	No
Secondary	Weight		week 0 and week 8	No
Secondary	fatty acids dosage	fatty acids dosage	week 0 and week 8	No
Secondary	number of adverse events		week 0 to week 8	Yes