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 |
| Protocol serial number | N0263107732 |
| Sponsor | Department of Health (UK) |
| Funder | University College London Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Gonadotrophin and sex hormone levels |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2003 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 20 |
| 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
- United Kingdom
- England
Study participating centre
Department of Paediatrics
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
