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

NCT04864509 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-29

No results posted yet for this study

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

Interventions

DRUG

Melatonin 10 MG

Nightly dose

DRUG

Placebo

Nightly dose

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Anne Kristine Amstrup · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-06-01
Completion
2024-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04864509 on ClinicalTrials.gov