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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004593
Receipt No. R000005486
Scientific Title The effects of 2 types of lutein supplements on macular pigment and visual functions
Date of disclosure of the study information 2010/11/22
Last modified on 2016/11/24

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Basic information
Public title The effects of 2 types of lutein supplements on macular pigment and visual functions
Acronym Macular pigment and visual functions
Scientific Title The effects of 2 types of lutein supplements on macular pigment and visual functions
Scientific Title:Acronym Macular pigment and visual functions
Region
Japan

Condition
Condition Macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the equality of 2 types of lutein supplements containing different lutein, Xanmax2002 and FloraGLO, on the increasing effects of macular pigment and plasma lutein concentrations in healthy persons. To investigate whether the increase in macular pigment improves retinal functions in a healthy eye.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Macular pigment optical density
Key secondary outcomes 1.Change in far and near visual acuity
2.Change in contrast sensitivity and glare-recovery testing
3.Change in response of macular electroretinogram
4.Change in plasma lutein concentration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Xanmax 2002 lutein supplement
Interventions/Control_2 FloraGLO lutein supplement
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria No serious eye diseases
Visual acuity of 0.8 and more
Myopia of less than -6.0 D
No gastrointestinal disorders such as malabsorption syndrome and history of gastrectomy causing absorption deficiency
No diabetes mellitus
No use of lutein and zeaxanthin supplements
Non-smoker or no tobacco smoking within the past 1 year
Providing informed consent with sufficient understanding of the present study
Judged by the investigator to be eligible as a subject on the basis of screening tests
Not allergic to lutein or zeaxanthin
Key exclusion criteria Presence of cataract of a severity sufficient to affect the measurement of macular pigment
Pupil size less than 6.5 mm
Judged by the investigator to be ineligible for other reasons
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Obana
Organization Seirei Hamamatsu General Hospital
Division name Department of Ophthalmology
Zip code
Address 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka 430-8558, Japan
TEL 053-474-2222
Email obana@sis.seirei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Asano
Organization Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name General Clinical Research Center
Zip code
Address 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka 430-8558, Japan
TEL 053-474-2222
Homepage URL
Email asanoma@sis.seirei.or.jp

Sponsor
Institute Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Institute
Department

Funding Source
Organization Koyo Mercantile Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 聖隷浜松病院眼科Department of Ophthalmology, Seirei Hamamatsu General Hospital

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2012 Year 06 Month 04 Day
Date of closure to data entry
2012 Year 08 Month 02 Day
Date trial data considered complete
2012 Year 09 Month 10 Day
Date analysis concluded
2012 Year 12 Month 06 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 20 Day
Last modified on
2016 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005486

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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