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Blind Child Melatonin Treatment Study

Primary Purpose

Blindness

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Melatonin
Melatonin
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blindness focused on measuring melatonin, circadian rhythms, sleep

Eligibility Criteria

5 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sleep and Mood Disorders Lab, Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.

Secondary Outcome Measures

Durability and Toxicity Side Effects Questionnaire

Full Information

First Posted
June 3, 2008
Last Updated
November 8, 2019
Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00691444
Brief Title
Blind Child Melatonin Treatment Study
Official Title
Melatonin Studies of Blind Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blindness
Keywords
melatonin, circadian rhythms, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
Melatonin
Intervention Description
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).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Durability and Toxicity Side Effects Questionnaire
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred J Lewy, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep and Mood Disorders Lab, Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16687313
Citation
Lewy AJ, Emens J, Jackman A, Yuhas K. Circadian uses of melatonin in humans. Chronobiol Int. 2006;23(1-2):403-12. doi: 10.1080/07420520500545862.
Results Reference
background
PubMed Identifier
10378763
Citation
Stores G, Ramchandani P. Sleep disorders in visually impaired children. Dev Med Child Neurol. 1999 May;41(5):348-52. doi: 10.1017/s0012162299000766. No abstract available.
Results Reference
background

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Blind Child Melatonin Treatment Study

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