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

January 11, 2008
September 16, 2009
September 2007
September 2009   (final data collection date for primary outcome measure)
The decrease in the severity in hot flashes. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00599456 on ClinicalTrials.gov Archive Site
Improvement in lipid profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hot Flashes
  • Menopause
  • Dietary Supplement: Omega 3 fatty acid vitamins
    Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months
  • Dietary Supplement: Placebo capsules
    Placebo capsules,2 capsules, by mouth, daily for 3 months
  • Experimental: 1
    Omega 3 vitamin supplements
    Intervention: Dietary Supplement: Omega 3 fatty acid vitamins
  • Placebo Comparator: 2
    Placebo capsule
    Intervention: Dietary Supplement: Placebo capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
up to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00599456
27103
No
Parastoo Farhady MD, Christiana Care Health Services
Christiana Care Health Services
Not Provided
Principal Investigator: Parastoo Farhady, MD Chrisitiana care Health Systems
Christiana Care Health Services
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP