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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaoming Lin, Peking University
ClinicalTrials.gov Identifier:
NCT01528605
First received: December 28, 2011
Last updated: August 18, 2014
Last verified: August 2014
Results First Received: July 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Age-related Macular Degeneration
Interventions: Dietary Supplement: placebo
Dietary Supplement: low lutein
Dietary Supplement: high lutein
Dietary Supplement: lutein plus zeaxanthin
Dietary Supplement: high zeaxanthin
Dietary Supplement: zeaxanthin plus lutein

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We added "High Zeaxanthin" and "High Lutein Zeaxanthin" Arms at the seconde year for additional information on the effect of zeaxanthin on MPOD and visual functions. Therefore, we did not measure the changes of serum concentration, and only measured the change of MOPD and visual functions at baseline and 48 weeks, in the two new groups.

Reporting Groups
  Description
Low Lutein

low lutein group

low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks

Placebo

starch in hard shell gelatine capsules

placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks

High Lutein

high lutein group

high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks

Low Lutein Zeaxanthin

lutein plus zeaxanthin group

lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks

High Zeaxanthin

zeaxanthin group

high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks

High Lutein Zeaxanthin

Zeaxanthin plus lutein group

zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks


Participant Flow:   Overall Study
    Low Lutein     Placebo     High Lutein     Low Lutein Zeaxanthin     High Zeaxanthin     High Lutein Zeaxanthin  
STARTED     28     28     28     28     28     28  
COMPLETED     26     28     27     27     28     28  
NOT COMPLETED     2     0     1     1     0     0  
Lost to Follow-up                 1                 0                 1                 1                 0                 0  
Death                 1                 0                 0                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
4 participants was excluded during the analysis since they did not finish the intervention.

Reporting Groups
  Description
Low Lutein

low lutein group

low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks

Placebo

starch in hard shell gelatine capsules

placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks

High Lutein

high lutein group

high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks

Low Lutein Zeaxanthin

lutein plus zeaxanthin group

lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks

High Zeaxanthin

zeaxanthin group

high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks

High Lutein Zeaxanthin

Zeaxanthin plus lutein group

zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks

Total Total of all reporting groups

Baseline Measures
    Low Lutein     Placebo     High Lutein     Low Lutein Zeaxanthin     High Zeaxanthin     High Lutein Zeaxanthin     Total  
Number of Participants  
[units: participants]
  26     28     27     27     28     28     164  
Age  
[units: years]
Mean ± Standard Deviation
  69.7  ± 8.3     69.0  ± 7.5     69.3  ± 6.9     68.5  ± 6.9     69.7  ± 5.4     69.1  ± 8.1     69.2  ± 7.6  
Gender  
[units: participants]
             
Female     17     17     13     15     17     15     94  
Male     9     11     14     12     11     13     70  
Region of Enrollment  
[units: participants]
             
China     26     28     27     27     28     28     164  



  Outcome Measures
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1.  Primary:   Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years   [ Time Frame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention ]

2.  Secondary:   Changes of Serum Xanthophylls Concentrations During the Intervention   [ Time Frame: at baseline and 4, 12, 24 and 48 weeks during the intervention ]

3.  Secondary:   Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention   [ Time Frame: at baseline and 24 weeks, 48 weeks, 2 years during the intervention ]

4.  Secondary:   Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention   [ Time Frame: at baseline, 24, 48 weeks and 2 years during the intervention ]
Results not yet posted.   Anticipated Posting Date:   12/2015   Safety Issue:   No

5.  Secondary:   Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer   [ Time Frame: at baseline, 24, 48 weeks and 2 years during the intervention ]
Results not yet posted.   Anticipated Posting Date:   12/2015   Safety Issue:   No

6.  Secondary:   Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks   [ Time Frame: at baseline and 48 weeks during the intervention ]
Results not yet posted.   Anticipated Posting Date:   12/2015   Safety Issue:   No

7.  Secondary:   Changes From Baseline in Microperimetry (MP) During the Intervention   [ Time Frame: at baseline, 24, 48 weeks and 2 years during the intervention ]
Results not yet posted.   Anticipated Posting Date:   12/2015   Safety Issue:   No

8.  Secondary:   Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention   [ Time Frame: at baseline, 24, 48 weeks and 2 years ]
Results not yet posted.   Anticipated Posting Date:   12/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Xiaoming Lin
Organization: Peking University
phone: 010-82805336
e-mail: linbjmu@bjmu.edu.cn


No publications provided by Peking University

Publications automatically indexed to this study:

Responsible Party: Xiaoming Lin, Peking University
ClinicalTrials.gov Identifier: NCT01528605     History of Changes
Other Study ID Numbers: NNSFC-30872113
Study First Received: December 28, 2011
Results First Received: July 20, 2014
Last Updated: August 18, 2014
Health Authority: China: National Natural Science Foundation