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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

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

Arm Label

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

NCT ID

NCT00691444

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)

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

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

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

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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