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NCT05784090 Clinical Trial

Correlation Between Melatonin Levels in Different Biological Fluids

Neurodegenerative Diseases Clinical Trial

Official title:
Livelli di Melatonina e Dei Suoi Precursori/Metaboliti in Differenti Fluidi Biologici: vi è Correlazione?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05784090
Other study ID # 21C821
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 23, 2018
Est. completion date December 31, 2023

Study information
Verified date March 2023
Source Istituto Auxologico Italiano
Contact Stefania Cattaldo
Phone 0323514345
Email s.cattaldo@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to evaluate and to correlate melatonin levels in plasma, saliva and cerebrospinal fluid (CSF) samples of patients undergoing lumbar puncture diagnostic for specific neurological diseases.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - Neurodegenerative disease Exclusion Criteria: - Age < 18 years - Pregnancy - Coagulations disorders - Anticoagulant therapy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• blood and saliva sample and lumbar puncture diagnostic for specific neurological diseases
Saliva was collected using Salivettes (Sarsted, Newton, NC, USA) in dim light. CSF was obtained in the morning after overnight fasting by lumbar puncture at the L3/L4 or L4/L5 interspace. Blood samples were drawn in fasting conditions. Plasma was separated by centrifugation.

Locations
Country Name City State
Italy Istituto Auxologico Italiano - S. Giuseppe Hospital Verbania VB

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Melatonin levels in saliva Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml Baseline
Primary Melatonin levels in plasma Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml Baseline
Primary Melatonin levels in cerebrospinal fluid Analysis of melatonin levels by ELISA kit. Values expressed in pg/ml Baseline
Secondary Orexin levels in cerebrospinal fluid Analysis of orexin levels by ELISA kit. Values expressed in ng/ml Baseline
Secondary Neurofilaments light chain levels (NFL) in cerebrospinal fluid Analysis of NFL levels by SIMOA kit. Values expressed in pg/ml Baseline
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