NCT00599456

Brief Summary

Hot flashes can be a disturbing symptom of menopause. Prescription medications are commonly used for symptom relief. Several non-prescription therapies are under investigation. This study will examine the use of omega-3 (fish oil) supplements to see if it helps relieve hot flashes and therefore improve the quality of life. Study Hypotheses: Menopausal women who take Omega 3 vitamins(fish oils)will show improvement in the severity of their hot flashes.In addition women who take Omega 3 supplements will show improvement in their lipid profiles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

January 11, 2008

Last Update Submit

May 9, 2017

Conditions

Hot FlashesMenopause

Keywords

Hot flashesMenopauseOmega 3 fatty Acids

Outcome Measures

Primary Outcomes (1)

  • The decrease in the severity in hot flashes.

    3 months

Secondary Outcomes (1)

  • Improvement in lipid profile

    3 months

Study Arms (2)

1

EXPERIMENTAL

Omega 3 vitamin supplements

Dietary Supplement: Omega 3 fatty acid vitamins

2

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Placebo capsules

Interventions

Omega 3 fatty acid vitaminsDIETARY_SUPPLEMENT

Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months

1
Placebo capsulesDIETARY_SUPPLEMENT

Placebo capsules,2 capsules, by mouth, daily for 3 months

2

Eligibility Criteria

AgeUp to 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Post menopausal females (no periods for over 6 months)
  • Documented Serum FSH level\>20
  • Positive urine FSH test
  • Hot flashes, on average five a day

You may not qualify if:

  • No EPT/ET
  • OTC supplements: ex; soy, black cohosh, flax, bellergal, primrose oil, vitamin E, red clover
  • Excessive smoking \> 1ppd
  • Anti seizure medications
  • Clonidine
  • Effexor
  • More than 2 servings of fish per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Systems

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Parastoo Farhady, MD

    Chrisitiana care Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 23, 2008

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

US(1)