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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
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blinded
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Melatonin

Arm Intervention/treatment
Active Comparator: Melatonin 10mg
Nightly oral dose
Drug: Melatonin 10 MG
Nightly dose

Placebo Comparator: Placebo
nightly oral dose
Drug: Placebo
Nightly dose




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Cardiovascular health [ Time Frame: After study completion. Up to one year ]
    Changes in 24h blood pressure and arterial stiffness measured by standardized equipment



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-presentation
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Post-menopausal women between 55 and 75 years

Exclusion Criteria:

  • 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
  • Smokers

Information from the National Library of Medicine

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


Contacts
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Contact: Anne Kristine Amstrup 78 45 54 75 anneamst@rm.dk

Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Anne Kristine Amstrup Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04864509    
Other Study ID Numbers: 2020-AKA
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants