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

Osteoporosis, Postmenopausal Clinical Trial

Official title:

The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure in Post Menopausal Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04864509
• Other study ID #: 2020-AKA
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2020
• Source: University of Aarhus
• Contact: Anne Kristine Amstrup
• Phone: 78 45 54 75
• Email: anneamst[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Melatonin 10 MG
Nightly dose
• Placebo
Nightly dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	Cardiovascular health	Changes in 24h blood pressure and arterial stiffness measured by standardized equipment	After study completion. Up to one year