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

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ClinicalTrials.gov Identifier: NCT01528605
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaoming Lin, Peking University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 168
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Low Lutein Placebo High Lutein Low Lutein Zeaxanthin High Zeaxanthin High Lutein Zeaxanthin
Hide Arm/Group Description

low lutein group

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

starch in hard shell gelatine capsules

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

high lutein group

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

lutein plus zeaxanthin group

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

zeaxanthin group

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

Zeaxanthin plus lutein group

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

Period Title: Overall Study
Started 28 28 28 28 28 28
Completed 26 28 27 27 28 28
Not Completed 2 0 1 1 0 0
Reason Not Completed
Lost to Follow-up             1             0             1             1             0             0
Death             1             0             0             0             0             0
Arm/Group Title Low Lutein Placebo High Lutein Low Lutein Zeaxanthin High Zeaxanthin High Lutein Zeaxanthin Total
Hide Arm/Group Description

low lutein group

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

starch in hard shell gelatine capsules

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

high lutein group

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

lutein plus zeaxanthin group

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

zeaxanthin group

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

Zeaxanthin plus lutein group

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

Total of all reporting groups
Overall Number of Baseline Participants 26 28 27 27 28 28 164
Hide Baseline Analysis Population Description
4 participants was excluded during the analysis since they did not finish the intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 28 participants 27 participants 27 participants 28 participants 28 participants 164 participants
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 27 participants 27 participants 28 participants 28 participants 164 participants
Female
17
  65.4%
17
  60.7%
13
  48.1%
15
  55.6%
17
  60.7%
15
  53.6%
94
  57.3%
Male
9
  34.6%
11
  39.3%
14
  51.9%
12
  44.4%
11
  39.3%
13
  46.4%
70
  42.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 26 participants 28 participants 27 participants 27 participants 28 participants 28 participants 164 participants
26 28 27 27 28 28 164
1.Primary Outcome
Title Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years
Hide Description

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.

Time Frame at baseline and 24 weeks, 48 weeks, 2 years during the intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Low Lutein High Lutein Low Lutein Zeaxanthin High Zeaxanthin High Lutein Zeaxanthin
Hide Arm/Group Description:

starch in hard shell gelatine capsules

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

low lutein group

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

high lutein group

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

lutein plus zeaxanthin group

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

zeaxanthin group

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

Zeaxanthin plus lutein group

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

Overall Number of Participants Analyzed 28 26 27 27 28 28
Mean (Standard Deviation)
Unit of Measure: density units
baseline 0.315  (0.144) 0.307  (0.142) 0.315  (0.122) 0.320  (0.118) 0.327  (0.117) 0.300  (0.168)
24 weeks 0.310  (0.102) 0.353  (0.125) 0.395  (0.120) 0.356  (0.150) NA [1]   (NA) NA [2]   (NA)
48 weeks 0.316  (0.110) 0.371  (0.188) 0.424  (0.142) 0.384  (0.125) 0.384  (0.139) 0.383  (0.179)
2 years 0.324  (0.163) 0.442  (0.127) 0.441  (0.133) 0.383  (0.149) NA [1]   (NA) NA [2]   (NA)
[1]
High zeaxanthin Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of MPOD from baseline to 48 weeks is all we needed for this purpose.
[2]
"High Lutein Zeaxanthin" Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of MPOD from baseline to 48 weeks is all we needed for this purpose.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Low Lutein, High Lutein, Low Lutein Zeaxanthin
Comments The null hypothesis was no group difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Changes of Serum Xanthophylls Concentrations During the Intervention
Hide Description 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.
Time Frame at baseline and 4, 12, 24 and 48 weeks during the intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Low Lutein High Lutein Low Lutein Zeaxanthin
Hide Arm/Group Description:

starch in hard shell gelatine capsules

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

low lutein group

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

high lutein group

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

lutein plus zeaxanthin group

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

Overall Number of Participants Analyzed 28 26 27 27
Mean (Standard Deviation)
Unit of Measure: μmol/L
baseline 0.330  (0.404) 0.318  (0.251) 0.301  (0.225) 0.244  (0.263)
4 weeks 0.258  (0.206) 0.870  (0.573) 1.041  (0.661) 0.965  (0.711)
12 weeks 0.355  (0.356) 1.058  (0.571) 1.450  (0.930) 1.121  (0.800)
24 weeks 0.281  (0.261) 0.973  (0.618) 1.450  (0.856) 1.109  (0.567)
48 weeks 0.403  (0.225) 1.350  (0.503) 1.876  (0.907) 1.136  (0.542)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Low Lutein, High Lutein, Low Lutein Zeaxanthin
Comments The null hypothesis was no group difference
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention
Hide Description 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.
Time Frame at baseline and 24 weeks, 48 weeks, 2 years during the intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Low Lutein High Lutein Low Lutein Zeaxanthin High Zeaxanthin High Lutein Zeaxanthin
Hide Arm/Group Description:

starch in hard shell gelatine capsules

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

low lutein group

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

high lutein group

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

lutein plus zeaxanthin group

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

zeaxanthin group

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

Zeaxanthin plus lutein group

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

Overall Number of Participants Analyzed 27 26 26 26 27 26
Mean (Standard Deviation)
Unit of Measure: letters
baseline 53.037  (9.338) 54.769  (10.285) 54.539  (8.056) 56.840  (6.440) 56.481  (7.073) 55.038  (7.977)
24 weeks 53.444  (12.509) 54.042  (10.519) 56.444  (8.617) 56.160  (14.907) NA [1]   (NA) NA [2]   (NA)
48 weeks 53.148  (10.741) 56.250  (10.920) 56.846  (10.035) 60.875  (4.919) 61.600  (8.093) 58.500  (9.437)
2 years 55.115  (12.385) 56.840  (7.587) 56.074  (7.770) 56.600  (11.839) NA [1]   (NA) NA [2]   (NA)
[1]
High zeaxanthin Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of BSCVA from baseline to 48 weeks is all we needed for this purpose.
[2]
"High Lutein Zeaxanthin" Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of BSCVA from baseline to 48 weeks is all we needed for this purpose.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Low Lutein, High Lutein, Low Lutein Zeaxanthin
Comments The null hypothesis is "no group difference"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention
Hide Description [Not Specified]
Time Frame at baseline, 24, 48 weeks and 2 years during the intervention
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer
Hide Description Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks
Time Frame at baseline, 24, 48 weeks and 2 years during the intervention
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks
Hide Description [Not Specified]
Time Frame at baseline and 48 weeks during the intervention
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Changes From Baseline in Microperimetry (MP) During the Intervention
Hide Description Microperimetry (MP) was measured by the MP1 Microperimeter
Time Frame at baseline, 24, 48 weeks and 2 years during the intervention
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention
Hide Description [Not Specified]
Time Frame at baseline, 24, 48 weeks and 2 years
Outcome Measure Data Not Reported
Time Frame 2 years, and ask for notable adverse effects for an average interval of 1 month.
Adverse Event Reporting Description 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. Subjects were encouraged to report any adverse effects immediately, and were asked specifically about adverse events such as carotenoderma every month during visits.
 
Arm/Group Title Placebo Low Lutein High Lutein Low Lutein Zeaxanthin High Zeaxanthin High Lutein Zeaxanthin
Hide Arm/Group Description

starch in hard shell gelatine capsules

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

low lutein group

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

high lutein group

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

lutein plus zeaxanthin group

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

zeaxanthin group

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

Zeaxanthin plus lutein group

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

All-Cause Mortality
Placebo Low Lutein High Lutein Low Lutein Zeaxanthin High Zeaxanthin High Lutein Zeaxanthin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Low Lutein High Lutein Low Lutein Zeaxanthin High Zeaxanthin High Lutein Zeaxanthin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/26 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Low Lutein High Lutein Low Lutein Zeaxanthin High Zeaxanthin High Lutein Zeaxanthin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/26 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Xiaoming Lin
Organization: Peking University
Phone: 010-82805336
EMail: linbjmu@bjmu.edu.cn
Layout table for additonal information
Responsible Party: Xiaoming Lin, Peking University
ClinicalTrials.gov Identifier: NCT01528605     History of Changes
Other Study ID Numbers: NNSFC-30872113
First Submitted: December 28, 2011
First Posted: February 8, 2012
Results First Submitted: July 20, 2014
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014