Blind Child Melatonin Treatment Study

November 8, 2019 updated by: Oregon Health and Science University

Melatonin Studies of Blind Children

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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).

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: 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 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).

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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Durability and Toxicity Side Effects Questionnaire
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (ESTIMATE)

June 5, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eIRB 1251
  • R01HD042125 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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