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
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.
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.
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