Blind Child Melatonin Treatment Study

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ClinicalTrials.gov Identifier: NCT00691444

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 : June 5, 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

Study Description

Brief Summary:

The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of blind children to the 24-hour day.

Condition or disease	Intervention/treatment	Phase
Blindness	Dietary Supplement: Melatonin Biological: Melatonin	Not Applicable

Detailed Description:

We intend to study as many as 26 blind children through up to three melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. The 3 treatment plans differ only in the start dose. Successfully treated subjects (of one treatment plan) will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Melatonin Studies of Blind Children
Study Start Date :	September 2002
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Subjects will be given up to 0.5 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.	Dietary Supplement: Melatonin Subjects will be given up to 0.5 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).
Experimental: 2 Subjects will be given up to 10 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.	Dietary Supplement: Melatonin Subjects will be given up to 10 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).
Experimental: 3 Subjects will be given up to 20 mg daily. If the treatment works, the dose will be reduced gradually until the lowest, effective dose is identified. If the treatment is unsuccessful, the subject will be taken off treatment and later enrolled in a different treatment plan.	Biological: Melatonin Subjects will be given up to 20 mg daily. 0.005-20 mg, daily, up to 5 years (the exact duration depends on each subjects response to the dose and the specifics of their circadian rhythm patterns).

Outcome Measures

Primary Outcome Measures :

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples. [ Time Frame: biweekly throughout the entire study ]

Secondary Outcome Measures :

Durability and Toxicity Side Effects Questionnaire [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 20 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children and adults 5 to 20 years old
Blindness for at least one year, verified by an ophthalmologic exam
Ability to comply with the requirements of the experimental protocol
And no clinically significant abnormalities (other than blindness) on a general physical examination.
Subjects must be competent to sign informed consent if age 18 or older. Parents and subjects will be interviewed together and, when appropriate (for example, subject is age 18 or older), separately as well.

Exclusion Criteria:

Abnormal heart, liver or kidney function; intractable seizure disorders
Significant laboratory abnormalities on CBC, Comprehensive Metabolic set, or UA (dip stick method)
Pregnancy; sexual activity in post-pubertal females not using a recognized and valid contraceptive method
A current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual ; OR
External demands that limit the ability to maintain a regular schedule, e.g. night shift work.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691444

Locations

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United States, Oregon
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

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Principal Investigator:	Alfred J Lewy, MD, PhD	Oregon Health and Science University

More Information

Publications:

Lewy AJ, Emens J, Jackman A, Yuhas K. Circadian uses of melatonin in humans. Chronobiol Int. 2006;23(1-2):403-12. Review.

Stores G, Ramchandani P. Sleep disorders in visually impaired children. Dev Med Child Neurol. 1999 May;41(5):348-52. Review.

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Responsible Party:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00691444
Other Study ID Numbers:	eIRB 1251 R01HD042125 ( U.S. NIH Grant/Contract )
First Posted:	June 5, 2008 Key Record Dates
Results First Posted:	November 27, 2019
Last Update Posted:	November 27, 2019
Last Verified:	November 2019

Keywords provided by Oregon Health and Science University:


melatonin circadian rhythms sleep

Additional relevant MeSH terms:

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Blindness Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Eye Diseases	Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants

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