Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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This study requires you to have blood drawn twice, record your hot flashes for a total of 3 weeks, and to take a product every day for 12 weeks. It will also entail 4 visits and up to 4 telephone contacts. The information you provide will be maintained in a database accessible only to the primary investigator and research team. You will be assigned a code number for your blood work and all other information. The key to this code will be maintained in this database.

Overall 60-100 women will be recruited for this study locally. During the course of the study you will get overall two blood draws amounting to up to a teaspoon for measurement of your cholesterol and fat levels.

This project consists of three phases.

Phase I

We will ask you questions about your medical history and your health. You will then be asked to provide a urine sample which will be used to confirm your menopausal status with a FSH level. You will be requested to keep a record of your hot flashes for one week using a symptom diary. Upon completion of the diary, you will return to the study site. If you qualify for participation, you will have blood work done to measure your cholesterol and other fat levels through a lipid panel. You will be provided with these results free of charge at the conclusion of the study.

Phase 2

You will receive the study medication. Half of the participants will receive the actual product we are investigating and half will receive a placebo (inactive/dummy pill). Neither you nor the investigators will not know which one you are given until the end of the study. During the 4th and 12th weeks, you will be asked to keep a diary (similar to the first one) of your hot flashes.

Phase 3

At the end of the 12 week study period, you will return to the study center. The second blood draw will be done to monitor any changes. This will conclude your participation. You will be sent a copy of your cholesterol profiles and FSH levels approximately 2 weeks after you complete the study.

Conditions

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Hot Flashes Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Omega 3 vitamin supplements

Group Type EXPERIMENTAL

Omega 3 fatty acid vitamins

Intervention Type DIETARY_SUPPLEMENT

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

2

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Omega 3 fatty acid vitamins

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

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes