Blind Child Melatonin Treatment Study
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ClinicalTrials.gov Identifier: NCT00691444 |
Recruitment Status :
Terminated
(Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.)
First Posted : June 5, 2008
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
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Condition or disease | Intervention/treatment | Phase |
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Blindness | Dietary Supplement: Melatonin Biological: Melatonin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Melatonin Studies of Blind Children |
Study Start Date : | September 2002 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

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.
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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). |
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.
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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.
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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). |
- Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples. [ Time Frame: biweekly throughout the entire study ]
- Durability and Toxicity Side Effects Questionnaire [ Time Frame: 1 year ]

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Ages Eligible for Study: | 5 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691444
United States, Oregon | |
Sleep and Mood Disorders Lab, Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Alfred J Lewy, MD, PhD | Oregon Health and Science University |
Responsible Party: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00691444 |
Other Study ID Numbers: |
eIRB 1251 R01HD042125 ( U.S. NIH Grant/Contract ) |
First Posted: | June 5, 2008 Key Record Dates |
Results First Posted: | November 27, 2019 |
Last Update Posted: | November 27, 2019 |
Last Verified: | November 2019 |
melatonin circadian rhythms sleep |
Blindness Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Eye Diseases |
Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |