Lutein and zeaxanthin supplementation in preterm infants to prevent retinopathy of prematurity
| ISRCTN | ISRCTN10624844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10624844 |
| Protocol serial number | 01/2008 |
| Sponsor | University of Florence (Italy) |
| Funder | SOOFT Italia S.p.a. (Italy) |
- Submission date
- 12/05/2011
- Registration date
- 15/06/2011
- Last edited
- 23/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Retinopathy of prematurity is a disease that occurs in premature babies where abnormal blood vessels grow in the retina (the layer of nerve tissue in the eye). This growth can cause the retina to detach from the back of the eye, causing blindness. The aim of this study is to find out whether lutein and zeaxanthin supplements can prevent retinopathy of prematurity in preterm infants.
Who can participate?
Preterm infants (gestational age 32 weeks or less)
What does the study involve?
Participants are randomly allocated to receive a daily dose of lutein and zeaxanthin or a placebo (dummy drug) until discharged from hospital. The occurrence of retinopathy of prematurity is recorded in both groups to see whether the supplement prevents retinopathy of prematurity.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Careggi University Hospital of Florence (Italy)
When is the study starting and how long is it expected to run for?
February 2008 to February 2011
Who is funding the study?
SOOFT Italia S.p.a. (Italy)
Who is the main contact?
Prof. Carlo Dani
Contact information
Scientific
Division of Neonatology
Careggi University Hospital of Florence
Largo Brambilla 3
Forence
50141
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre prospective randomised double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | LUtein and zeaxanthin SUpplementation in Preterm infants to prevent RetinOpathy of Prematurity: a multicentre prospective randomised double-blind placebo-controlled study |
| Study acronym | LUSUPROP Study |
| Study objectives | Retinopathy of prematurity (ROP) that was classified according to the International Classification as follows: Stage 1, a thin demarcation line separates the avascular retina anteriorly from the vascularized retina posteriorly Stage 2, a ridge arises in the region of the demarcation line and extends above the plane of the retina Stage 3, neovascularization extends from the ridge into the vitreous Stage 4, there is partial retinal detachment; stage 5, there is total retinal detachment Moreover, increased venous dilation and arteriolar tortuosity are markers of severe active ROP and are referred to as plus disease. Lutein and zeaxanthin supplementation may decrease the occurrence of retinopathy of prematurity (ROP) in high risk preterm infants. |
| Ethics approval(s) | Ethics Committee for Clinical Trials of Medicines, University Hospital Careggi (Comitato Eitco per la sperimentazione clinica dei medicinali, Azienda ospedaliera Universitaria Careggi), 25/05/2007, ref: 38/2009 |
| Health condition(s) or problem(s) studied | Retinopathy of prematurity (ROP) |
| Intervention | Infants at each unit were grouped in blocks: 1. 1st block: gestational age < 25+6 weeks 2. 2nd block: gestational age from 26+0 to 28+6 weeks 3. 3rd block: gestational age > 29+0 weeks) Infants were randomly assigned to a treatment group using the sealed envelope technique which were prepared at Careggi University Hospital of Florence and then distributed to participating centres. Each infant received a daily oral dose of 0.5 ml containing 0.14 mg of lutein and 0.006 mg of zeaxanthin (LUTEINofta®, Sooft Italia, Montegiorgio, Italy) or indistinguishable placebo. Supplementation was begun from the 1st to the 7th day of life and was given until discharge. Lutein/Zeaxanthin (L/Z) or placebo were given before feeding or added to breast milk (from the infant's mother or a donor) or to infant formula. Age and duration of supplementation were recorded. Time of initial feeding, use of breast milk or preterm infant formula, and change from preterm infant formula to term infant formula were at the discretion of the attending physician. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. The successful rate of lutein and zeaxanthin supplementation at preventing ROP |
| Key secondary outcome measure(s) |
1. Gestational and post-natal age at ROP diagnosis |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 242 |
| Key inclusion criteria | Infants with gestational age < 32 weeks after parental informed consent |
| Key exclusion criteria | 1. The presence of major congenital malformation 2. Fetal hydrops 3. Death before the first ophthalmologic examination 3. Lack of lutein supplementation > 10 days during the first 30 days of life 4. Development of aggressive-posterior ROP (AP-ROP) |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
50141
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/05/2017: Plain English summary added.
