Trial record 7 of 72 for:
Open Studies | "Dermatitis, Atopic"
Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis
This study is currently recruiting participants.
Verified January 2012 by National Taiwan University Hospital
Sponsor:
National Taiwan University Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01638234
First received: July 8, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in AD patients. However, there has been no large randomized controlled trials. Hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with AD.
| Condition | Intervention |
|---|---|
|
Atopic Dermatitis |
Dietary Supplement: Melatonin Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Melatonin Supplement in the Management of Sleep Disturbances in Children With Atopic Dermatitis |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- Objective sleep measures as measured by polysomnography and actigraphs [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]parameters including sleep latency, sleep efficiency, activity, and wake episodes and duration
Secondary Outcome Measures:
- urine and serum cytokines [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]serum levels of melatonin, urinary levels of 6-hydroxymelatonin sulfate, and serum levels of cytokines associated with sleep regulation including IL-10, IL-6, IL-4, IL-1b, and IL-31
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Starch pill |
Dietary Supplement: Placebo
starch pill
|
| Experimental: Melatonin |
Dietary Supplement: Melatonin
melatonin 3 mg tab 1 tab po hs for 4 weeks
|
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Children between 1 and 18 years of age with mild to moderate AD, affecting at least 5% of total body surface area, and with sleep problems in the previous 3 months
Exclusion Criteria:
- Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine
- Those who had received therapy for insomnia within 4 weeks before the baseline visit
- Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments
- Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully
- Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication
- Pregnant and lactating women and those who are presently planning to get pregnant
- Those who had any other condition or earlier/current treatment which, in the opinion of the investigator, would render the participant ineligible for the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638234
Contacts
| Contact: Jyh-Hong Lee, MD | +886928272767 | leonid@ntu.edu.tw |
| Contact: Bor-Luen Chiang, MD, PhD | +886223123456 ext 71715 | gicmbor@ntu.edu.tw |
Locations
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Jyh-Hong Lee, MD +886928272767 leonid@ntu.edu.tw | |
| Principal Investigator: Jyh-Hong Lee, MD | |
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
| Principal Investigator: | Jyh-Hong Lee, MD | National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01638234 History of Changes |
| Other Study ID Numbers: | 200902026M |
| Study First Received: | July 8, 2012 |
| Last Updated: | July 8, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
atopic dermatitis eczema |
Additional relevant MeSH terms:
|
Dermatitis, Atopic Dermatitis Sleep Disorders Dyssomnias Parasomnias Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders Melatonin Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on June 17, 2013