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

Menopause Clinical Trial

Official title:

A Placebo Controlled Double Blinded Prospective Study to Investigate the Usefulness of Omega 3 Fatty Acids in the Relief of Vasomotor Symptoms of Menopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599456
• Other study ID #: 27103
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: May 9, 2017
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: May 2017
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 65 Years

Eligibility

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

• A 2 week pre study washout period of exclusion criteria

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

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Dietary Supplement:
• Omega 3 fatty acid vitamins
Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months
• Placebo capsules
Placebo capsules,2 capsules, by mouth, daily for 3 months

Locations

Country	Name	City	State
United States	Christiana Care Health Systems	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The decrease in the severity in hot flashes.		3 months
Secondary	Improvement in lipid profile		3 months