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Melatonin Studies of Totally Blind Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795236
Recruitment Status : Terminated (Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.)
First Posted : November 21, 2008
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE November 19, 2008
First Posted Date  ICMJE November 21, 2008
Results First Submitted Date  ICMJE April 7, 2014
Results First Posted Date  ICMJE November 27, 2019
Last Update Posted Date November 27, 2019
Study Start Date  ICMJE November 2009
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
  • To Test for a Proportional Gender Difference in Circadian Status (Free-running Versus Entrained) in Blind Children and in Adolescents, a Chi-square Test of Significance Will be Used for Each Age Group. [ Time Frame: Approximately 1 year ]
  • To Test for a Proportional Difference in Circadian Status (Free-running Versus Entrained) Between Pre and Post- Pubertal Males in Blind Boys and Young Men, a Chi-square Test of Significance Will be Used for Each Age Group. [ Time Frame: Approximately 1 year ]
  • To Determine the Efficacy of Melatonin Treatment in Entraining Blind Free-running Children and Young Adults, a Binomial Test Will be Used. [ Time Frame: Approximately 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2008)
  • To Test for a Proportional Gender Difference in Circadian Status (Free-running Versus Entrained) in Blind Children and in Adolescents, a Chi-square Test of Significance Will be Used for Each Age Group. [ Time Frame: November 1, 2012 ]
  • We will utilize a binomial test to determine the efficacy of melatonin in entraining free-running blind children by examining the percentage of participants who entrain to 0.5 mg of melatonin. [ Time Frame: November 1, 2012 ]
Change History Complete list of historical versions of study NCT00795236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Melatonin Studies of Totally Blind Children
Official Title  ICMJE Melatonin Studies in Young Blind Children and Adolescents
Brief Summary The purpose of this study is to learn more about abnormal body rhythms in blind boys and girls that keep them from falling asleep at bed-time or cause them difficulty staying alert during the day. The investigators hope to learn if there are any differences between the body rhythms of girls and boys. The investigators also want to investigate whether age or puberty have an effect on body rhythms.
Detailed Description Subjects will be asked to collect saliva samples in their home hourly throughout the daytime, approximately every 2 weeks. Subjects may be monitored for up to a year, after which they will be discontinued from the study. If subjects are found to be naturally entrained to the 24-hour day, they will be monitored longitudinally for changes. Subjects will be discontinued after their monitoring period is over or after an entrained status has been confirmed. While no specific time commitment is required, we hope most subjects will participant for 4 months - 2 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Disorder
  • Blindness
Intervention  ICMJE Drug: Melatonin
One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.
Study Arms  ICMJE
  • No Intervention: Observational
    Observe to determine free-running versus entrained status.
  • Experimental: Melatonin
    Subjects with free-running rhythms will take melatonin.
    Intervention: Drug: Melatonin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 8, 2019)
13
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2008)
90
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Totally blind
  • Between 5-8 yrs or 17-20 yrs of age

Exclusion Criteria:

  • Pregnancy
  • Light perception
  • Low melatonin production
  • Taking melatonin
  • Co-morbid medical disorders (such as seizure disorders)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00795236
Other Study ID Numbers  ICMJE eIRB 4664
2R01HD042125-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Alfred Lewy, MD, PhD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP