Blind Child Melatonin Treatment Study

NCT00691444 | Terminated Results DMC

• 2 other identifiers: eIRB 1251R01HD042125
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Blindness

Keywords

melatonin; circadian rhythms; sleep

Outcome Measures

Primary Outcomes (1)

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

  biweekly throughout the entire study

Secondary Outcomes (1)

• Durability and Toxicity Side Effects Questionnaire

  1 year

Study Arms (3)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

3

EXPERIMENTAL

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

Interventions

Melatonin DIETARY_SUPPLEMENT

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).

1

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Sleep and Mood Disorders Lab, Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• 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.

  PMID: 16687313 BACKGROUND

• 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.

  PMID: 10378763 BACKGROUND

MeSH Terms

Conditions

Blindness

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Analyses were not completed because, a unique provision in the American Recovery and Reinvestment Act (ARRA) of 2009 funding source unexpectedly prevented approval of a second year no-cost-extension in which completion of analyses were planned.

Results Point of Contact

• Title: OHSU Integrity Department
• Organization: Oregon Health and Science University

irb@ohsu.edu

1-877-733-8313

Study Officials

• Alfred J Lewy, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: September 1, 2002
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (1)