The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure
NCT ID: NCT04864509
Last Updated: 2021-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2021-05-01
2024-06-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Melatonin 10mg
Nightly oral dose
Melatonin 10 MG
Nightly dose
Placebo
nightly oral dose
Placebo
Nightly dose
Interventions
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Melatonin 10 MG
Nightly dose
Placebo
Nightly dose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* Smokers
55 Years
75 Years
FEMALE
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Anne Kristine Amstrup
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Central Contacts
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Other Identifiers
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2020-AKA
Identifier Type: -
Identifier Source: org_study_id
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