Contact information
Type
Scientific
Primary contact
Dr RM Viner
ORCID ID
Contact details
Department of Paediatrics
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
-
a@b.c
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0263107732
Study information
Scientific title
A blinded randomised cross-over study of the effect of melatonin treatment of sleep disturbances on hypothalamic-pituitary-gonadal axis and leptin in pubertal children
Acronym
Study hypothesis
What is the effect of melatonin on the hypothalamic-pituitary-gonadal axis in pubertal adolescents?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nervous System Diseases: Sleep disorders
Intervention
1. Melatonin
2. Placebo
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Gonadotrophin and sex hormone levels
2. Urinary melatonin
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2001
Overall trial end date
01/09/2003
Reason abandoned (if study stopped)
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20 patients from paediatrics
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2001
Recruitment end date
01/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Paediatrics
London
W1N 8AA
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University College London Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list