The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure in Post Menopausal Women
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Gene expression
研究概览
简要总结
Melatonin protects your bones while losing fat! This was previously demonstrated by our group. The mechanisms behind these findings are still elusive, and the aim of the present study is to assess the mechanisms.
In a double-blinded randomized controlled trial 40 postmenopausal woman are randomized to receive either 10 mg melatonin or placebo nightly for three months. Changes in gene expression in marrow cells will be assessed through micro array. Markers of bone metabolism will be assessed through biochemical markers. Cardiovascular health will be measured by tonometry and 24h blood pressure.
The results of the study will contribute with important knowledge about the beneficial effects of melatonin making it an interesting supplement to known treatment regimens against osteoporosis and overweight.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal women between 55 and 75 years
排除标准
- •Severely impaired renal function
- •Severely impaired hepatic function
- •Coagulation factors PP<0.6
- •Hypercalcemia (p-ion calcium >1.32 nmol/l)
- •Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy)
- •Diseases affecting the calcium homeostasis including untreated thyroid diseases
- •Regular use of medicine affecting the calcium homeostasis, including diuretics, fenemal, lithium, antiepileptica and glucosteroids
- •Selective serotonin reuptake inhibitor (SSRI)-products with fluvoxamin
- •Treatment with carbamazepin
- •Treatment with rifampicin
- •Severe malabsorption syndrome including gastric or intestinal resection
- •Alcohol or drug abuse
研究组 & 干预措施
Melatonin 10mg
Nightly oral dose
干预措施: Melatonin 10 MG (Drug)
Placebo
nightly oral dose
干预措施: Placebo (Drug)
结局指标
主要结局
Gene expression
时间窗: After study completion. Up to one year
Changes in gene expression in human mesenchymal stem cells.The biopsies are put on freeze after obtaining them. All biopsies are analysed at once.
次要结局
- Cardiovascular health(After study completion. Up to one year)
- Biochemical markers(After study completion. Up to one year)
- Quality of sleep(After study completion. Up to one year)