Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration

Age-related Macular Degeneration Clinical Trial

Official title:

The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528605
• Other study ID #: NNSFC-30872113
• Status: Completed
• Phase: N/A
• First received: December 28, 2011
• Last updated: August 18, 2014
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.

Description:

Early age-related macular degeneration (AMD) is an early hallmark of irreversible vision impairment accompanying with senescence of macular. Given the fact in treatment, prevention strategy is thought to be an efficient and robust approach to diminish early AMD patients in low-income countries, however, feasible cocktail provision in most developing nations remain mysteries. Here we proposed an effective cocktail treatment with different amounts of lutein and zeaxanthin could increase the macular pigment optical density (MPOD) and serum xanthophylls concentrations among randomized Chinese AMD patients; and might improve visual function measured by visual performance indices such as best-spectacle corrected visual acuity (BSCVA), contrast sensitivity (CSF), flash recovery time (FRT), multifocal electroretinogram (mfERG) and microperimetry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• aged over 50 years, Chinese of the Han nationality

• diagnosed as age-related macular degeneration

• did not take lutein or zeaxanthin supplements in the past half a year

• good general health

• corrected visual acuity above 0.25 (20/80)

• did not take optical laser or medical treatments

Exclusion Criteria:

• had other ocular diseases, such as glaucoma, macular pucker, optic neuropathy, diabetic retinopathy etc.

• had nervous system diseases, stroke, Type I diabetes

• had diseases effected nutrients absorption, such as Crohn' s disease

• had turbid ocular media or transplanted intraocular lenses

• reported abnormal digestive condition

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Dietary Supplement:
• placebo
Placebo, one gelatine capsule containing starch per day, for 96 weeks
• low lutein
one gelatine capsule containing 10mg lutein per day, for 96 weeks
• high lutein
one gelatine capsule containing 20mg lutein per day, for 96 weeks
• lutein plus zeaxanthin
one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks
• high zeaxanthin
one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks
• zeaxanthin plus lutein
one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks

Locations

Country	Name	City	State
China	Haidian District	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years	Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values.; 4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.	at baseline and 24 weeks, 48 weeks, 2 years during the intervention	No
Secondary	Changes of Serum Xanthophylls Concentrations During the Intervention	Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.	at baseline and 4, 12, 24 and 48 weeks during the intervention	No
Secondary	Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention	best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.	at baseline and 24 weeks, 48 weeks, 2 years during the intervention	No
Secondary	Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention		at baseline, 24, 48 weeks and 2 years during the intervention	No
Secondary	Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer	Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks	at baseline, 24, 48 weeks and 2 years during the intervention	No
Secondary	Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks		at baseline and 48 weeks during the intervention	No
Secondary	Changes From Baseline in Microperimetry (MP) During the Intervention	Microperimetry (MP) was measured by the MP1 Microperimeter	at baseline, 24, 48 weeks and 2 years during the intervention	No
Secondary	Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention		at baseline, 24, 48 weeks and 2 years	No