UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007628 |
|---|---|
| Receipt number | R000009006 |
| Scientific Title | A multi-center, randomized, parallel-group study to assess the changes in macular pigment density and visual performance in the patients with age-related macular degeneration, who received a lutein supplement |
| Date of disclosure of the study information | 2012/04/20 |
| Last modified on | 2023/10/10 09:27:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multi-center, randomized, parallel-group study to assess the changes in macular pigment density and visual performance in the patients with age-related macular degeneration, who received a lutein supplement
Acronym
A multi-center study to assess the macular pigment density and visual performance in age-related macular degeneration
Scientific Title
A multi-center, randomized, parallel-group study to assess the changes in macular pigment density and visual performance in the patients with age-related macular degeneration, who received a lutein supplement
Scientific Title:Acronym
A multi-center study to assess the macular pigment density and visual performance in age-related macular degeneration
Region
| Japan |
Condition
Condition
Patients with hemilateral age-related macular degeneration (AMD)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess changes in the macular pigment density, visual performance, and plasma lutein level in the eye which is normal or has early age-related maculopathy (ARM) during the 6-month continuous intake of a lutein supplement or placebo in the subjects who have age-related macular degeneration (late ARM) in one eye and have early ARM or no ARM in the fellow eye.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
macular pigment density
Key secondary outcomes
visual acuity, contrast sensitivity, glare sensitivity, plasma lutein level, OCT retinal thickness at the central fovea
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects are to take a soft capsule containing lutein 20 mg once a day for six months.
Interventions/Control_2
The subjects are to take a placebo soft capsule in the same shape once a day for six months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Asian
Patient who has hemilateral AMD and normal fellow eye or early ARM in the fellow eye. The normal or early ARM eye is to be assessed as the subject eye.
Follow the definition of the precursory lesion presented in the diagnostic criteria) of the Japanese Ophthalmological Society when making the diagnosis of early ARM. More specifically,
Diagnose the patient as having early ARM in the eye when having either of soft drusen (one or more drusen of not less than 63micrometer in diameter) or retinal pigment epithelial abnormalities (absence of the pigment, pigmentation, pigment unevenness, small (less than one papillary diameter) serous retinal pigment epithelial detachment).
Patient of 50 years or over of age at consent, who is able to give written consent
No visual acuity criteria. If the patient has corrected vision of 0.7 or under, the investigator needs to pay adequate attention for the presence or absence of the disease other than early ARM.
No gender criteria
Patient assessed eligible by the investigator based on the results of the screening tests
Patient who has no allergy to lutein or zeaxanthin
Key exclusion criteria
Eye with cataract to the degree having substantial effects on the measurement of the macular pigment density. Exclude nuclear cataract of Grade 2 or severer nuclear sclerosis.
The subject should be disqualified when having marked progression of cataract in the subject eye during the study period.
The subject should be disqualified when undergoing the cataract surgery during the study period.
Eye of which mydriatic pupil diameter is less than 6.5 mm
Eye with glaucoma, diabetic retinopathy, or other serious disease
Myopia of -6D or over
Patient having as severe hepatic/renal impairment or cardiac disease as affecting the evaluation of the investigational supplement
Patient continuously treated with any photo-sensitive drug (phenothiazine,
chloroquine, tetracycline, etc.)
Patient who constantly used lutein within 3 months
Other subject assessed ineligible by the investigator
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Ophthalmology
Zip code
430-8558
Address
1-12-12 Sumiyoshi, Naka-ku
TEL
0534742222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Asano |
Organization
Seirei Hamamatsu General Hospital
Division name
General Clinical Research Center
Zip code
430-8558
Address
1-12-12 Sumiyoshi, Naka-ku
TEL
0534742222
Homepage URL
obana@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Dixon Laser Inst, Univ of Utah.
Med Photonics Res Center, Hamamatsu Univ.
Inflam Ophthalmol, Hokkaido Univ Grad School.
Ophthalmol, Moran Eye Center, Univ of Utah.
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Hamamatsu City, Shizuoka Prefecture 430-8558
Tel
053-474-2222
asanoma@sis.seirei.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学大学院医学研究科医学専攻研究眼科学講座(北海道）
日本大学医学部眼科(東京都）
聖隷浜松病院眼科(静岡県）
神戸大学医学部眼科(兵庫県）
島根大学医学部眼科(島根県）
Department of Ophthalmology, Hokkaido University Graduate School of Medicine(Hokkaido)
Department of Ophthalmology, Nihon University School of Medicine(Tokyo)
Department of Ophthalmology, Seirei Hamamatsu General Hospital(Shizuoka)
Division of Ophthalmology, Kobe University Graduate School of Medicine(Hyogo)
Department of Ophthalmology, Shimane University School of Medicine(Shimane)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
84
Results
There was no statistically significant difference in the mean MPOD at baseline between both groups.
The MPODs were almost equivalent after six months in both groups. There was no significant difference in the mean serum utein concentration at baseline between both groups. The mean serum concentration increased in six months, although it wasn't significant. In lutein group, 23 subjects showed increase of serum concentration of more than 20% that was significantly higher than placebo group.(p=0.035)
Results date posted
| 2019 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
d 27 normal eyes and 14 eyes with early ARM.There were no significant differences in age, gender and lens status between placebo and lutein groups.
Participant flow
Eighty-four eyes of 84 subjects were enrolled in this study. Two eyes in placebo group failed to measure MPOD at one time point during the study period (month 1 in one patient, month 9 in one patient), and these two eyes were excluded from the following analyses. Thus, forty-one eyes of 41 subjects in placebo group and forty-one eyes of 41 subjects in lutein group were analyzed.
Adverse events
No adverse events related to the study supplements were reported during the study period.
Outcome measures
Mean (SD) MPOD levels in Raman counts at baseline were 4266 (3377) in placebo group and 4283 (4011) in lutein group.
After the start of supplementation, the MPOD levels were almost equivalent up to the end of supplementation in either group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 01 | Day |
Other
Other related information
We were unable to reach the target number of cases during the setup period of the study. As a result, we did not proceed with the publication with the findings.
Management information
Registered date
| 2012 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
