Does additional vitamin A supplementation improve retinal function in very low birth weight infants?
DEC-NET Serial number GB510
Published online01/11/2005 10.26.00
Last updated07/11/2005 9.53.03
This trial has been approved by an ethics committee
Current trial statusPlanned (i.e. not yet recruiting participants)
Major Disease
(ICD9 class)		RETROLENTAL FIBROPLASIA
Experimental drug
RETINOL (VIT A)
GenderBoth
Age (range)newborn

Eligibility criteria
Inclusion criteria
Infants born before 32 completed weeks of gestation and/or <1500grams birth weight, who are admitted to either Princess Royal Maternity or Queen Mother's Hospital neonatal units within the firat 24 hours of life.
Exclusion criteria
Congenital ocular abnormality

Trial design/methodology
Phase4
Kind of studyProphylaxis
DesignControlled
Randomised
Blinded
Single blind
Purpose of study
To measure the effect of high dose Intramuscular vitamin A supplementation on retinal function in Very low birth weight infants and to establish whether retinal function is related to total intake of vitamin A, hepatic stores and/or conjunctival health.
Primary outcomes
Retinal function at 36 corrected weeks as measured by the electroretinogram.
Secondary outcomes
Conjunctival cell health and hepatic stores of vitamin A at 36 corrected weeks and plasma levels of vitamin A at birth 7, and 28 days.
Summary of study design, objectives, and ongoing research findings
A randomised Controlled Trial to assess the prophylactic efficacy of high dose retinol on retinal function in very low birth weight infants.
Principal investigator
NameDr Helen Mactier
InstitutionPrincess Royal Maternity
Postal addressNeonatal Unit, Princess Royal Maternity, 8-16 Alexandra Parade
CityGlasgow, G31 2ER
CountryUNITED KINGDOM
Phone0141 2115407
Fax0141 2115348
E-mailHelen.mactier@northglasgow.scot.nhs.uk


Sponsor name
Great Glasgow NHS Board Yorkhill Division (NHS)


Participating centres
Princess Royal Maternity (Glasgow)
Queen Mother's Hospital (Glasgow)

ISRCTN  EudraCT  2005-003402-29