Effects of Vitamin C and Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by The Hong Kong Polytechnic University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01142960
First received: June 10, 2010
Last updated: June 11, 2010
Last verified: May 2010
  Purpose

With the rapid growing aging population, age-related eye diseases including cataract are becoming more prevalent. The demand for cataract surgery and post-surgical care posed enormous financial burdens to the government.

Vitamin C, also known as ascorbate, is a highly effective antioxidant which may help to protect the cells including the crystalline lens components from oxidative damage, which is believed to be one of the causes of senile cataract.

Lycium barbarum, on the other hand, contains lutein and zeaxanthin which can filter the phototoxic blue light and neutralize the reactive oxygen species, thus provide a protective effect against cataract formation.

This study aims to determine the effects of Vitamin C and Lycium barbarum Supplements on the progression of senile cataract in Hong Kong Chinese elderly.


Condition Intervention
Lens Opacity
Dietary Supplement: Starch
Dietary Supplement: Vitamin C
Dietary Supplement: Lycium Barbarum

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Vitamin C and Lycium Barbarum Supplements on the Progression of Senile Cataract in Hong Kong Chinese Population

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Lens Opacity Classification System III (LOCSIII) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Starch
1350mg/day
Active Comparator: Vitamin C Dietary Supplement: Vitamin C
500mg Vitamin C plus 850mg Starch/day
Active Comparator: Lycium Barbarum Dietary Supplement: Lycium Barbarum
1350mg/day

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unlikely to have cataract surgery within 3 years
  • Presence of mild to moderate cataract in one or both eyes, graded by Lens Opacities Classification System III (LOCSIII).
  • logMAR acuity equivalent to Snellen acuity of 20/63 or better
  • no previous history and clinical signs of glaucoma by determining intraocular pressure using applanation Tonometry (no more than 22mmHg)
  • no ocular anomalies: amblyopia, binocular anomalies, ocular trauma
  • no history of eye surgery, laser treatment, iritis, retinal crystalline deposits, macular degeneration, or optic nerve diseases
  • no extended use of systemic or ocular corticosteroid drugs
  • no concurrent participation of other systemic or ocular drug intervention study

Exclusion Criteria:

  • diabetes mellitus
  • renal failure
  • fat malabsorption syndrome
  • intestinal surgery history
  • chronic diarrhea
  • alcoholism
  • use of anticoagulants
  • regular use of nutritional supplements such as multi-vitamin, mineral and other antioxidant supplements (including Omega-3)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142960

Contacts
Contact: Chi-wai Do, PhD 27666090 socwdo@inet.polyu.edu.hk
Contact: Chea-su Kee, PhD 27667941 sokee@inet.polyu.edu.hk

Locations
Hong Kong
The Hong Kong Polytechnic University Not yet recruiting
Hung Hom, Kowloon, Hong Kong, 0000
Contact: Chi-wai Do, PhD    27666090    socwdo@inet.polyu.edu.hk   
Contact: Chea-su Kee, PhD    27667941    sokee@inet.polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Chi-wai Do, PhD The Hong Kong Polytechnic University
Principal Investigator: Chea-su Kee, PhD The Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Chi-wai Do & Chea-su Kee/ Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01142960     History of Changes
Other Study ID Numbers: 5-ZH73
Study First Received: June 10, 2010
Last Updated: June 11, 2010
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 26, 2014