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

NCT04864509 | Unknown Phase 4 DMC

• 1 other identifier: 2020-AKA
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Biochemical markers

  After study completion. Up to one year

• Quality of sleep

  After study completion. Up to one year

• Cardiovascular health

  After study completion. Up to one year

Study Arms (2)

Melatonin 10mg

ACTIVE COMPARATOR

Nightly oral dose

Drug: Melatonin 10 MG

Placebo

PLACEBO COMPARATOR

nightly oral dose

Drug: Placebo

Interventions

Melatonin 10 MG DRUG

Nightly dose

Melatonin 10mg

Placebo DRUG

Nightly dose

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Gender Eligibility Details: self-presentation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women between 55 and 75 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Anne Kristine Amstrup

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Kristine Amstrup

CONTACT

78 45 54 75; anneamst@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: April 29, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2024
• Last Updated: April 29, 2021

Record last verified: 2020-06