Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis
NCT01638234 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2015-04-20
Summary
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Melatonin
melatonin 3 mg tab 1 tab po hs for 4 weeks
- DIETARY_SUPPLEMENT
-
Placebo
starch pill
Sponsors & Collaborators
-
National Taiwan University Hospital
lead OTHER
Principal Investigators
-
Jyh-Hong Lee, MD · National Taiwan University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 1 Year
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2013-04-30
- Completion
- 2013-04-30
Countries
- Taiwan
Study Locations
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