The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure
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|ClinicalTrials.gov Identifier: NCT04864509|
Recruitment Status : Not yet recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis, Postmenopausal||Drug: Melatonin 10 MG Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||double blinded|
|Official Title:||The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure in Post Menopausal Women|
|Estimated Study Start Date :||May 1, 2021|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2024|
Active Comparator: Melatonin 10mg
Nightly oral dose
Drug: Melatonin 10 MG
Placebo Comparator: Placebo
nightly oral dose
- Gene expression [ Time Frame: 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.
- Biochemical markers [ Time Frame: After study completion. Up to one year ]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
- Quality of sleep [ Time Frame: After study completion. Up to one year ]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.
- Cardiovascular health [ Time Frame: After study completion. Up to one year ]Changes in 24h blood pressure and arterial stiffness measured by standardized equipment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864509
|Contact: Anne Kristine Amstrup||78 45 54 email@example.com|
|Principal Investigator:||Anne Kristine Amstrup||Aarhus University Hospital|