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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin 10mg | Active Comparator | Nightly oral dose |
|
| Placebo | Placebo Comparator | nightly oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 10 MG | Drug | Nightly dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression | Changes in gene expression in human mesenchymal stem cells.The biopsies are put on freeze after obtaining them. All biopsies are analysed at once. | After study completion. Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical markers | Changes in biochemical markers of bone metabolism measured in blood: Markers include PTH (pmol/l), ionized calcium (mmol/l) CTX (ug/l). Although different units they all contribute to the overall evaluation of bone metabolism and must therefore be regarded as the same outcome measure | After study completion. Up to one year |
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Inclusion Criteria:
Exclusion Criteria:
self-presentation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Kristine Amstrup | Contact | 78 45 54 75 | anneamst@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Anne Kristine Amstrup | Aarhus University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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double blinded
| Drug |
Nightly dose |
|
| Quality of sleep | Assessed through the questionnaire Pittsburgh quality of sleep questionnaire. A validated questionnaire assessing the quality of sleep. A score between 0-5 indicates a good quality of sleep. Scores above 5 indicate a poor quality of sleep. | After study completion. Up to one year |
| Cardiovascular health | Changes in 24h blood pressure and arterial stiffness measured by standardized equipment | After study completion. Up to one year |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |