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
| ISRCTN | ISRCTN31542578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31542578 |
| Secondary identifying numbers | N0263107732 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 13/12/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr RM Viner
Scientific
Scientific
Department of Paediatrics
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
| a@b.c |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Study objectives | What is the effect of melatonin on the hypothalamic-pituitary-gonadal axis in pubertal adolescents? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Sleep disorders |
| Intervention | 1. Melatonin 2. Placebo |
| Intervention type | Other |
| Primary outcome measure | 1. Gonadotrophin and sex hormone levels 2. Urinary melatonin |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2001 |
| Completion date | 01/09/2003 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 20 patients from paediatrics |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Paediatrics
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University College London Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
13/12/2019: Study stopped due to lack of resources.
12/12/2019: No publications found, verifying study status with principal investigator.
