Blind Child Melatonin Treatment Study

Blindness Clinical Trial

Official title:

Melatonin Studies of Blind Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00691444
• Other study ID #: eIRB 1251
• Secondary ID: R01HD042125
• Status: Terminated
• Phase: N/A
• Start date: September 2002
• Est. completion date: December 2015

Study information

• Verified date: November 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blindness

Intervention

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).
• 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).

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).

Locations

Country	Name	City	State
United States	Sleep and Mood Disorders Lab, Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.		biweekly throughout the entire study
Secondary	Durability and Toxicity Side Effects Questionnaire		1 year