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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599456
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : May 10, 2017
Information provided by (Responsible Party):
Christiana Care Health Services

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Menopause Dietary Supplement: Omega 3 fatty acid vitamins Dietary Supplement: Placebo capsules Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: 1
Omega 3 vitamin supplements
Dietary Supplement: Omega 3 fatty acid vitamins
Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months

Placebo Comparator: 2
Placebo capsule
Dietary Supplement: Placebo capsules
Placebo capsules,2 capsules, by mouth, daily for 3 months

Primary Outcome Measures :
  1. The decrease in the severity in hot flashes. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Improvement in lipid profile [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599456

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United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
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Principal Investigator: Parastoo Farhady, MD Chrisitiana care Health Systems

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Responsible Party: Christiana Care Health Services Identifier: NCT00599456     History of Changes
Other Study ID Numbers: 27103
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Christiana Care Health Services:
Hot flashes
Omega 3 fatty Acids

Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms
Growth Substances
Physiological Effects of Drugs