NCT02062528

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

February 12, 2014

Last Update Submit

December 8, 2015

Conditions

Hot FlashesFatty AcidsMenopause

Keywords

EPA

Outcome Measures

Primary Outcomes (1)

  • hot flashes frequency

    ANOVA by repeated measures

    1 to 8 week

Secondary Outcomes (10)

  • hot flashes frequency difference

    4 week and 8 week

  • diurnal hot flashes

    week 1 to 8

  • night hot flashes

    week 1 to 8

  • vasomotors disorders

    week 1 to week 8

  • Pittsburgh Sleep Quality Index (PSQI)

    week 0 and week 8

  • +5 more secondary outcomes

Study Arms (2)

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

omega-3 fatty acidsDIETARY_SUPPLEMENT

highly dosed in EPA

Also known as: groupe actif
omega-3 fatty acids
placeboDIETARY_SUPPLEMENT
placebo

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • menopause or peri menopause
  • complaining of hot flashes
  • social security affiliation
  • informed consent form signed

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigation clinique CIC1406

Grenoble Cedex9, 38043, France

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Jean-Luc CRACOWSKI, MD-PhD

    Centre d'investigation clinique CIC1406

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 13, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

July 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

FR(1)