The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure

Phase 4

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: Melatonin 10 MG; Drug: Placebo

• Registration Number: NCT04864509
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Study First Posted: 2021-04-29
• Last Update Posted: 2021-04-29
• Study Start: 2021-05-01
• Primary Completion: 2022-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin 10mg	Melatonin 10 MG	Nightly oral dose
Placebo	Placebo	nightly oral dose

Primary Outcome Measures

Name	Time	Method
Gene expression	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

Name	Time	Method
Cardiovascular health	After study completion. Up to one year	Changes in 24h blood pressure and arterial stiffness measured by standardized equipment
Biochemical markers	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	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.