Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by National Taiwan University Hospital
Sponsor:
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
  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:

  1. Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine
  2. Those who had received therapy for insomnia within 4 weeks before the baseline visit
  3. Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments
  4. Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully
  5. Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication
  6. Pregnant and lactating women and those who are presently planning to get pregnant
  7. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014