UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007041 |
|---|---|
| Receipt number | R000008302 |
| Scientific Title | A prospective, randomized, double blind study comparing lutein to placebo for reducing occurrence and severity of retinopathy of prematurity, and evaluating antioxidative power and central visual function. |
| Date of disclosure of the study information | 2012/01/20 |
| Last modified on | 2012/01/09 22:06:14 |
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Basic information
Public title
A prospective, randomized, double blind study comparing lutein to placebo for reducing occurrence and severity of retinopathy of prematurity, and evaluating antioxidative power and central visual function.
Acronym
Lutein supplementation in preterm infants. A RCT.
Scientific Title
A prospective, randomized, double blind study comparing lutein to placebo for reducing occurrence and severity of retinopathy of prematurity, and evaluating antioxidative power and central visual function.
Scientific Title:Acronym
Lutein supplementation in preterm infants. A RCT.
Region
| Europe |
Condition
Condition
Preterm infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of retinopathy of prematurity, evaluation of antioxidative power and central visual function after administration of lutein to a population of preterm neonates.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence and severity of retinopathy of prematurity; biological antioxidative power; central visual function.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Administration of oral supplementation of Lutein
Interventions/Control_2
Administration of oral placebo
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
| 24 | weeks-old | <= |
Age-upper limit
| 34 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
Gestational age less than or equal to 34 weeks; ability to tolerate minimal enteral feeding before the seventh day of life; parent consent
Key exclusion criteria
Congenital malformations; chromosomal abnormalities
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Romagnoli Costantino |
Organization
Catholic University of the Sacred Heart
Division name
Pediatrics
Zip code
Address
Largo Francesco Vito 8 - 00168 Rome Italy
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Catholic University of the Sacred Heart
Division name
Pediatrics
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Catholic University of the Sacred Heart
Institute
Department
Personal name
Funding Source
Organization
Catholic University of the Sacred Heart
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 09 | Day |
Last modified on
| 2012 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008302
