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CompletedNCT00528151Updated Dec 24, 2012

A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)

A Phase 3 interventional study of curcumin in Optic Atrophy, Hereditary, Leber, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-24.

Sponsored by Mahidol University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
8 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Optic Atrophy, Hereditary, Leber

Keywords

  • Curcumin, LHON, antioxidant, visual outcome
03

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • LHON patient with 11778 point mutation

Exclusion criteria

Exclusion Criteria:

  • LHON patient with other point mutation
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Placebo comparator
    2

    1. curcumin 2. placebo

    Drug: curcumin

Interventions

  • Drugcurcumin

    curcumin 250 mg twice a day in the first group. placebo 1 capsule twice a day in the second group.

05

What researchers measure

Primary outcomes

  1. visual outcome

    Time frame: 1 year

06

Study locations

1 site
  • Professor Wanicha Chuenkongkaew
    Bangkok, 10700, Thailand
07

Registry details

Key details

Study ID
NCT00528151
Lead sponsor
Mahidol University
First posted
Sep 12, 2007
Start date
May 2005
Completion
Dec 2007
Last update
Dec 24, 2012

Study contacts

Professor Wanicha L Chuenkongkaew, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2004. You cannot join it, but the record below documents what was studied.

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