An interventional study of Omega 3 fatty acid vitamins and Placebo capsules in Hot Flashes and Menopause, sponsored by Christiana Care Health Services. Completed at 1 site in United States. Open to female participants aged Up to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-10.
Sponsored by Christiana Care Health Services · Not applicable, Interventional, and Treatment
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.
285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 255 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Omega 3 vitamin supplements
Dietary Supplement: Omega 3 fatty acid vitamins
Placebo capsule
Dietary Supplement: Placebo capsules
Omega 3 fatty acid vitamins, 2 capsules, by mouth, daily, for 3 months
Placebo capsules,2 capsules, by mouth, daily for 3 months
The decrease in the severity in hot flashes.
Time frame: 3 months
Improvement in lipid profile
Time frame: 3 months
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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