The Influence of Melatonin Supplementation in the Group of Persons Performing Competitive Sport.
1 other identifier
interventional
81
0 countries
N/A
Brief Summary
The research aims to determine the impact of 30-day supplementation of melatonin on the antioxidative defense mechanisms and the release of markers of oxidative stress and inflammation in rowers and footballers undergoing training of submaximal intensity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2012
CompletedFirst Submitted
Initial submission to the registry
March 28, 2018
CompletedFirst Posted
Study publicly available on registry
April 23, 2018
CompletedApril 23, 2018
March 1, 2018
3 years
March 28, 2018
April 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of oxidative stress parameters and inflammatory markers concentration before melatonin administration, at baseline.
The study was conducted in football players and rowers and the control group. Samples of blood from the basilic vein were taken once, from both the control group and the athletes at baseline. In blood serum, the ELISA method was used to determine the concentrations of melatonin, isoprostanes (8-iso-PGF2α), anti-ox-LDL antibodies, interleukin-6 and C-reactive protein (CRP). In red blood cells, the concentration of reduced glutathione (GSH), thiobarbituric acid reactive substances (malondialdehyde, MDA) were determined and the activity of glutathione peroxidase (GSH-Px), cytoplasmic superoxide dismutase (SOD-1) and glutathione reductase (GR) were determined.
1 day
Secondary Outcomes (1)
Changes in oxidative stress parameters and inflammatory markers concentration afer 30 days of melatonin administration in athletes.
30 day
Study Arms (1)
melatonin, submaximal effort
EXPERIMENTAL1 arm 5 mg melatonin 1 hr before bedtime for 30 days
Interventions
Eligibility Criteria
You may qualify if:
- sign informed consent form for participation in the study
You may not qualify if:
- diseases
- the participants will not be minor and incapacitated persons, soldiers, prisoners and persons dependent in any way from the investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jolanta Czuczejko
Department of Positron Emission Tomography and Molcecular Diagnostics, Collegium Medicum of Nicolaus Copernicus University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
March 28, 2018
First Posted
April 23, 2018
Study Start
January 15, 2010
Primary Completion
December 31, 2012
Study Completion
December 31, 2012
Last Updated
April 23, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
There is no the IPD sharing plan.