A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)
Primary Purpose
Optic Atrophy, Hereditary, Leber
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
curcumin
Sponsored by
About this trial
This is an interventional treatment trial for Optic Atrophy, Hereditary, Leber focused on measuring Curcumin, LHON, antioxidant, visual outcome
Eligibility Criteria
Inclusion Criteria:
- LHON patient with 11778 point mutation
Exclusion Criteria:
- LHON patient with other point mutation
Sites / Locations
- Professor Wanicha Chuenkongkaew
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
2
Arm Description
curcumin placebo
Outcomes
Primary Outcome Measures
visual outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT00528151
First Posted
September 11, 2007
Last Updated
December 20, 2012
Sponsor
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT00528151
Brief Title
A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)
Official Title
A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder associated with a mutation in mtDNA . The common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production.
Purpose To determine whether curcumin which is an antioxidant agent is beneficial to the patients with 11778 LHON mutation.
Material and Method Seventy patients with 11778 LHON mutation were randomly treated with oral curcumin (500 mg/day) and placebo for 1 year. The visual acuity, computerized visual field, electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and after treatment at 3, 6, and 12 months interval.
Detailed Description
Leber's hereditary optic neuropathy (LHON) is a maternally inherited disease that is characterized by a simultaneous or more common sequential bilateral loss of central vision, which typically occurs during the teenager years or early adulthood. The disease may be progressive and the patients eventually become blind. In contrast to blindness in patients caused by congenital diseases, the patients who develop blindness caused by LHON will have more trouble in their life because they previously had better vision. Although LHON is associated with mitochondrial DNA mutation at a variable nucleotide position but no certain mechanism of optic nerve injury has been found. It has been postulated that a defect in a complex of respiratory chain enzyme which is caused by mitochondrial DNA dysfunction, results in an increase of free radical substances that interfere with optic nerve function in LHON. Some antioxidant substances have been used to decrease the progression of visual impairment. However, there have been few therapeutic trials for LHON.
Curcumin, a component of tumeric, which comes from the root Curcumin longa has antioxidant, anti-inflammatory and anti-carcinogenic activities. There is some evidence which suggests that curcumin contributes to the in vitro removal of free radical gradients in thalassemic serum and to a clinical improvement of thalassemic patients. We propose a randomized controlled trial study of curcumin, which is an antioxidant substance, for LHON. This study will provide not only an insight into the therapeutic efficacy of curcumin, a kind of Thai herb, for LHON but also the development of future therapeutic strategies to prevent blindness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Atrophy, Hereditary, Leber
Keywords
Curcumin, LHON, antioxidant, visual outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
curcumin
placebo
Intervention Type
Drug
Intervention Name(s)
curcumin
Intervention Description
curcumin 250 mg twice a day in the first group. placebo 1 capsule twice a day in the second group.
Primary Outcome Measure Information:
Title
visual outcome
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
LHON patient with 11778 point mutation
Exclusion Criteria:
LHON patient with other point mutation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Wanicha L Chuenkongkaew, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professor Wanicha Chuenkongkaew
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)
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