Trial Outcomes & Findings for Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration (NCT NCT01528605)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

at baseline and 24 weeks, 48 weeks, 2 years during the intervention

Results posted on

2014-08-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	28	28	28	28	28	28
Overall Study COMPLETED	26	28	27	27	28	28
Overall Study NOT COMPLETED	2	0	1	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	1	0	1	1	0	0
Overall Study Death	1	0	0	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Lutein n=26 Participants low lutein group low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks	Placebo n=28 Participants starch in hard shell gelatine capsules placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks	High Lutein n=27 Participants high lutein group high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks	Low Lutein Zeaxanthin n=27 Participants lutein plus zeaxanthin group lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks	High Zeaxanthin n=28 Participants zeaxanthin group high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks	High Lutein Zeaxanthin n=28 Participants Zeaxanthin plus lutein group zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks	Total n=164 Participants Total of all reporting groups
Age, Continuous	69.7 years STANDARD_DEVIATION 8.3 • n=5 Participants	69.0 years STANDARD_DEVIATION 7.5 • n=7 Participants	69.3 years STANDARD_DEVIATION 6.9 • n=5 Participants	68.5 years STANDARD_DEVIATION 6.9 • n=4 Participants	69.7 years STANDARD_DEVIATION 5.4 • n=21 Participants	69.1 years STANDARD_DEVIATION 8.1 • n=8 Participants	69.2 years STANDARD_DEVIATION 7.6 • n=8 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	15 Participants n=4 Participants	17 Participants n=21 Participants	15 Participants n=8 Participants	94 Participants n=8 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	11 Participants n=21 Participants	13 Participants n=8 Participants	70 Participants n=8 Participants
Region of Enrollment China	26 participants n=5 Participants	28 participants n=7 Participants	27 participants n=5 Participants	27 participants n=4 Participants	28 participants n=21 Participants	28 participants n=8 Participants	164 participants n=8 Participants

PRIMARY outcome

Timeframe: at baseline and 24 weeks, 48 weeks, 2 years during the intervention

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.

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants starch in hard shell gelatine capsules placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks	Low Lutein n=26 Participants low lutein group low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks	High Lutein n=27 Participants high lutein group high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks	Low Lutein Zeaxanthin n=27 Participants lutein plus zeaxanthin group lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks	High Zeaxanthin n=28 Participants zeaxanthin group high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks	High Lutein Zeaxanthin n=28 Participants Zeaxanthin plus lutein group zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks
Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years 24 weeks	0.310 density units Standard Deviation 0.102	0.353 density units Standard Deviation 0.125	0.395 density units Standard Deviation 0.120	0.356 density units Standard Deviation 0.150	NA density units Standard Deviation NA 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.	NA density units Standard Deviation NA "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.
Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years 48 weeks	0.316 density units Standard Deviation 0.110	0.371 density units Standard Deviation 0.188	0.424 density units Standard Deviation 0.142	0.384 density units Standard Deviation 0.125	0.384 density units Standard Deviation 0.139	0.383 density units Standard Deviation 0.179
Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years 2 years	0.324 density units Standard Deviation 0.163	0.442 density units Standard Deviation 0.127	0.441 density units Standard Deviation 0.133	0.383 density units Standard Deviation 0.149	NA density units Standard Deviation NA 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.	NA density units Standard Deviation NA "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.
Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years baseline	0.315 density units Standard Deviation 0.144	0.307 density units Standard Deviation 0.142	0.315 density units Standard Deviation 0.122	0.320 density units Standard Deviation 0.118	0.327 density units Standard Deviation 0.117	0.300 density units Standard Deviation 0.168

SECONDARY outcome

Timeframe: at baseline and 4, 12, 24 and 48 weeks 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.

Outcome measures

Outcome measures
Measure	Placebo n=28 Participants starch in hard shell gelatine capsules placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks	Low Lutein n=26 Participants low lutein group low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks	High Lutein n=27 Participants high lutein group high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks	Low Lutein Zeaxanthin n=27 Participants 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
Changes of Serum Xanthophylls Concentrations During the Intervention 4 weeks	0.258 μmol/L Standard Deviation 0.206	0.870 μmol/L Standard Deviation 0.573	1.041 μmol/L Standard Deviation 0.661	0.965 μmol/L Standard Deviation 0.711	—	—
Changes of Serum Xanthophylls Concentrations During the Intervention 48 weeks	0.403 μmol/L Standard Deviation 0.225	1.350 μmol/L Standard Deviation 0.503	1.876 μmol/L Standard Deviation 0.907	1.136 μmol/L Standard Deviation 0.542	—	—
Changes of Serum Xanthophylls Concentrations During the Intervention baseline	0.330 μmol/L Standard Deviation 0.404	0.318 μmol/L Standard Deviation 0.251	0.301 μmol/L Standard Deviation 0.225	0.244 μmol/L Standard Deviation 0.263	—	—
Changes of Serum Xanthophylls Concentrations During the Intervention 12 weeks	0.355 μmol/L Standard Deviation 0.356	1.058 μmol/L Standard Deviation 0.571	1.450 μmol/L Standard Deviation 0.930	1.121 μmol/L Standard Deviation 0.800	—	—
Changes of Serum Xanthophylls Concentrations During the Intervention 24 weeks	0.281 μmol/L Standard Deviation 0.261	0.973 μmol/L Standard Deviation 0.618	1.450 μmol/L Standard Deviation 0.856	1.109 μmol/L Standard Deviation 0.567	—	—

SECONDARY outcome

Timeframe: at baseline and 24 weeks, 48 weeks, 2 years 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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants starch in hard shell gelatine capsules placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks	Low Lutein n=26 Participants low lutein group low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks	High Lutein n=26 Participants high lutein group high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks	Low Lutein Zeaxanthin n=26 Participants lutein plus zeaxanthin group lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks	High Zeaxanthin n=27 Participants zeaxanthin group high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks	High Lutein Zeaxanthin n=26 Participants Zeaxanthin plus lutein group zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks
Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention baseline	53.037 letters Standard Deviation 9.338	54.769 letters Standard Deviation 10.285	54.539 letters Standard Deviation 8.056	56.840 letters Standard Deviation 6.440	56.481 letters Standard Deviation 7.073	55.038 letters Standard Deviation 7.977
Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention 2 years	55.115 letters Standard Deviation 12.385	56.840 letters Standard Deviation 7.587	56.074 letters Standard Deviation 7.770	56.600 letters Standard Deviation 11.839	NA letters Standard Deviation NA 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.	NA letters Standard Deviation NA "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.
Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention 48 weeks	53.148 letters Standard Deviation 10.741	56.250 letters Standard Deviation 10.920	56.846 letters Standard Deviation 10.035	60.875 letters Standard Deviation 4.919	61.600 letters Standard Deviation 8.093	58.500 letters Standard Deviation 9.437
Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention 24 weeks	53.444 letters Standard Deviation 12.509	54.042 letters Standard Deviation 10.519	56.444 letters Standard Deviation 8.617	56.160 letters Standard Deviation 14.907	NA letters Standard Deviation NA 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.	NA letters Standard Deviation NA "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.

SECONDARY outcome

Timeframe: at baseline, 24, 48 weeks and 2 years during the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at baseline, 24, 48 weeks and 2 years during the intervention

Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at baseline and 48 weeks during the intervention

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at baseline, 24, 48 weeks and 2 years during the intervention

Microperimetry (MP) was measured by the MP1 Microperimeter

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at baseline, 24, 48 weeks and 2 years

Outcome measures

Other adverse events

Adverse event data not reported

Additional Information

Xiaoming Lin

Peking University

Phone: 010-82805336

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place