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

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00599456
First received: January 11, 2008
Last updated: September 16, 2009
Last verified: September 2009
  Purpose

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 Intervention
Hot Flashes
Menopause
Dietary Supplement: Omega 3 fatty acid vitamins
Dietary Supplement: Placebo capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • The decrease in the severity in hot flashes. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in lipid profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599456

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

No publications provided

Responsible Party: Parastoo Farhady MD, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00599456     History of Changes
Other Study ID Numbers: 27103
Study First Received: January 11, 2008
Last Updated: September 16, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014