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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The decrease in the severity in hot flashes.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •No EPT/ET
- •OTC supplements: ex; soy, black cohosh, flax, bellergal, primrose oil, vitamin E, red clover
- •Excessive smoking > 1ppd
- •Anti seizure medications
- •Clonidine
- •More than 2 servings of fish per week
结局指标
主要结局
The decrease in the severity in hot flashes.
时间窗: 3 months
次要结局
- Improvement in lipid profile(3 months)