NCT00691444

Blind Child Melatonin Treatment Study

Melatonin Studies of Blind Children

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 5 Years – 20 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Blindness

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2002-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2008-06-05
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

1 site across 1 country: United States