Effects of Lutein Supplementation in Japanese Patients with Unilateral Age-Related Macular Degeneration: The Sakai Lutein Study

UMIN000027962 | Sakai Lutein Study | Sawa M et al. (2020)

Sawa M, Shunto T, Nishiyama I, et al. Effects of Lutein Supplementation in Japanese Patients with Unilateral Age-Related Macular Degeneration: The Sakai Lutein Study. Sci Rep, 2020; 10:5958.

Locations

Single-center study in Japan

Study Period

October 2015 – December 2017

Study Design

Randomized, double-masked, parallel-group, single-center study

Study Population

Characteristic:

Type of AMD:

Dry

AMD Stage:

2 (Intermediate)

Total Sample Size:

39 patients were randomized (20 in the beeswax capsule group, 19 in the glycerol fatty acid esters capsule group)

Age:

Randomized, double-masked, parallel-group, single-center study

Sex (Male) n%:

24 (61.5%) (derived from group distributions)

Experimental Group

Intervention Therapy:

Lutein 20 mg + 3 mg zeaxanthin in beeswax-based capsules

Dose & Frequency:

One capsule per day for 6 months

Age (Years):

69.5 ± 5.6

Number of Patients:

20 randomized and treated

Male N %:

13 (65.0%)

Patients Followed Up:

20 (100%)

Control Group

Intervention Therapy:

Lutein 20 mg + 3 mg zeaxanthin in glycerol fatty acid esters-based capsules

Dose & Frequency:

One capsule per day for 6 months

Age (Years):

72.0 ± 4.8

Number of Patients:

19 randomized and treated

Male N %:

11 (57.9%)

Patients Followed Up:

19 (100%)

Follow-up Time: 6 months

Outcomes

Durability

Not reported

Vision

Contrast Sensitivity Mean change in contrast sensitivity (AULCSF, glare conditions) at 6 months:
• Beeswax group: No significant change
• Glycerol FA esters group: No significant change.

Other

Mean change in plasma lutein concentration at 6 months:
• Beeswax group: +125.2 ng/mL
• Glycerol FA esters group: +95.5 ng/mL
• Difference: p =0.5171 Mean change in plasma lutein concentration at 3 months:
• Beeswax group: +101.4 ng/mL
• Glycerol FA esters group: +53.5 ng/mL
• Difference: p=0.0668

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Macular Pigment Optical Density (MPOD) The mean change in MPOD at 6 months (primary outcome):
• Beeswax group: +0.030 DU
• Glycerol FA esters group: +0.009 DU
• Difference: p = 0.9722 The mean change in MPOD at 3 months:
• Beeswax group: +0.007 DU
• Glycerol FA esters group: +0.006 DU
• Difference: p = 0.2891

Safety

Treatment-emergent AEs One case of yellow skin in the beeswax group (patient withdrew). Serious ocular AEs None reported. Non-ocular AEs None were reported, except for yellow skin in one patient.

Outcomes

Conclusion

Beeswax-based lutein supplementation resulted in a marginally significant increase in MPOD over 6 months, while glycerol fatty acid esters capsules did not. Plasma lutein concentration increased in both groups, but no significant effects on contrast sensitivity were observed.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Low risk
Note: “The beeswax and glycerol fatty acid esters capsule groups were randomized 1:1 using the block randomization method.” The baseline is balanced between the two groups.

Missing Outcome Data

Low risk
Note: No dropouts were mentioned.

Selection of the Reported Results

Low risk Note: registration with protocol

Deviations from Intended Observations

Low risk Note: This is a double-masked study. There were no dropouts for this study, so the ITT principle was applied.

Measurement of the Outcome

Low risk Note: This is a double-masked study in a single research site.

Overall

Low risk