NCT00417404|CompletedPhase 4DMC
Vitamin A and Very Low Birthweight Babies (VitAL)
Does Additional Vitamin A Supplementation Improve Retinal Function and Conjunctival Health in Very Low Birthweight Infants?
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Sponsor study identifier
Secondary identifiers
interventional
94
1 country
2
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Vitamin A is important for the development of healthy eyes and lungs. Very low birth weight premature babies have low body stores of vitamin A and are prone to diseases of the eye and lungs. Previous work has shown that intramuscular (IM) vitamin A reduces the number of babies who require prolonged oxygen therapy, and may also reduce the number of babies affected by retinopathy of prematurity (ROP)). There is also some evidence that the conjunctiva shows signs of deficiency of vitamin A in premature infants, particularly those who develop ROP. Our own work here in Glasgow suggests that, compared to babies born at full term, premature babies' eyes are less sensitive to light and we believe that this may reflect shortage of vitamin A in the eye. This study will examine the effects upon the eye of giving extra intramuscular vitamin A to very low birth weight, premature infants. We will also measure blood levels of vitamin A and calculate liver stores of this nutrient.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 29, 2006
Actual (reported)January 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 1, 2007
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)retinal function at 36 corrected weeks
36 corrected weeks
plasma levels of vitamin A at birth, 7 and 28 days
birth, 7 and 28 days
hepatic stores of vitamin A at 36 corrected weeks
36 corrected weeks
IM Aquasol A 10,000IU three times weekly
10,000 IU three times weeks, by intramuscular injection
Queen Mother's Hospital
Glasgow, G3 8SJ, United Kingdom
Princess Royal Maternity
Glasgow, G31 2ER, United Kingdom
Helen Mactier, MD
Glasgow Royal Infirmary
94 participants (actual enrollment reported by the registry).
First Submitted
December 29, 2006
First Posted
January 1, 2007
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Balanced Anesthesia for Intubation of Premature Infants
sham injection
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Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
June 25, 2010
Record last verified: 2010-06
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Source: ClinicalTrials.gov.
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