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| Sponsored by: |
Christiana Care Health Services |
|---|---|
| Information provided by: | Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT00599456 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Omega 3 vitamin supplements
|
Dietary Supplement: Omega 3 fatty acid vitamins
Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months
|
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2: Placebo Comparator
Placebo capsule
|
Dietary Supplement: Placebo capsules
Placebo capsules,2 capsules, by mouth, daily for 3 months
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tina M Grossman, RN, BSN, MSCC | 302-733-3062 | tgrossman@christianacare.org |
| Contact: Jennifer Benson, RN | 302-733-3065 | jebenson@christianacare.org |
| United States, Delaware | |
| Christiana Care Health Systems | Recruiting |
| Newark, Delaware, United States, 19718 | |
| Principal Investigator: Parastoo Farhady, MD | |
| Sub-Investigator: Patricia I Carney, MD, FACOG | |
| Sub-Investigator: William Hohman, MD | |
| Principal Investigator: | Parastoo Farhady, MD | Chrisitiana care Health Systems |
More Information
| Responsible Party: | Christiana Care Health Services ( Parastoo Farhady MD ) |
| Study ID Numbers: | 27103 |
| Study First Received: | January 11, 2008 |
| Last Updated: | February 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00599456 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Hot flashes Menopause Omega 3 fatty Acids |
|
Signs and Symptoms Vitamins Omega 3 Fatty Acid Hot Flashes |
Trace Elements Micronutrients Menopause |
|
Signs and Symptoms Growth Substances Vitamins Physiological Effects of Drugs |
Hot Flashes Micronutrients Pharmacologic Actions |
