Hot Flashes and Omega 3 | NCT02062528

Studies
Hot Flashes and Omega 3

NCT02062528

Sponsor

Vivatech

Status

Completed

Last Update Posted

Dec 9, 2015Estimated

Enrollment

136Actual

Phase

Not Applicable

Conditions

Hot Flashes
Fatty Acids
Menopause

Interventions

omega-3 fatty acids
placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

May 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Feb 12, 2014

First Submission Date that Met QC Criteria

Feb 12, 2014

First Posted Date

Feb 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2015

Last Update Posted Date

Dec 9, 2015Estimated

Name	Class
Centre d'Investigation Clinique de Grenoble CIC1406	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
omega-3 fatty acids	Experimental	3 capsules each day during 8 weeks	Dietary Supplement: omega-3 fatty acids
placebo	Placebo Comparator	3 capsules each day during 8 weeks	Dietary Supplement: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
omega-3 fatty acids	Dietary Supplement	highly dosed in EPA	omega-3 fatty acids

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
hot flashes frequency difference	difference betwwen week8 and week4 and week0	4 week and 8 week
diurnal hot flashes	ANOVA and difference

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Luc CRACOWSKI, MD-PhD	Centre d'investigation clinique CIC1406	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'investigation clinique CIC1406		Grenoble Cedex9		38043	France

Condition Browse Module

MeSH Terms

ID	Term
D019584	Hot Flashes

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015525	Fatty Acids, Omega-3

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided