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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Aarhus
• Treatments: Melatonin

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