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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Neurodegenerative Diseases

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