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Vitamin A and Very Low Birthweight Babies (VitAL)

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ClinicalTrials.gov Identifier: NCT00417404
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : June 25, 2010
Chief Scientist Office of the Scottish Government
Information provided by:
Glasgow Royal Infirmary

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preterm Birth Retinopathy of Prematurity Drug: Aquasol A Drug: aquasol A Other: sham injection Phase 4

Detailed Description:

Eligible infant will be those infants born at < 32 completed weeks gestation and/or weighing < 1501 grams birth weight who have been admitted to either Princess Royal Maternity or Queen Mother's Hospital within the first 24 hours of life. If informed, written consent is obtained within 48-72 hours of birth, the infant will be randomised into either control or intervention group.

The intervention group will receive IM vitamin A (Aquasol A)10,000IU three times weekly; control infants will receive mock injections. Injections will be continued for 4 weeks (maximum 12 injections). If enteral feeds are tolerated (defined as more than 75% of predicted intake via the enteral route)after the 14th day, oral vitamin A (as part of a multivitamin preparation) will be commenced and IM vitamin A discontinued. The dose of oral vitamin A will be 5000IU daily (= 0.6ml Dalivit), continued through discharge from the neonatal unit until the first birthday. The same oral vitamin supplement will be given to all VLBW babies, whether or not enrolled in this study. For infants receiving parenteral nutrition, Vitlipid N infant (4ml/kg/day) will be commenced on day 2, or at the discretion of the attending neonatologist. This will be given in addition to IM vitamin A.

The study design is partially blinded whereby control infants will have mock injections (as described by Tyson et al.), rather than placebo injections. Infants randomised to placebo will simply have a sticking plaster applied to a leg prior to the screens being withdrawn. The research nurse will therefore be blinded to the infant's randomisation.

Blood samples will be collected from enrolled infants at birth (or immediately after randomisation), on day 7, day 28 and at 36 corrected weeks. Samples will be separated, frozen and plasma retinol subsequently analysed by high pressure liquid chromatography.

The RDR test will be performed as close as practicable to 36 corrected weeks, and whenever possible in conjunction with routine blood sampling. The baby will be given oral vitamin A, 2000IU/kg, and a second specimen of blood obtained 3 hours after administration of vitamin A. As well as measurement of plasma retinol concentration, red blood cells will be analysed for the DHA content of the cell membrane.

Retinal function will be assessed using the electroretinogram (ERG), in conjunction with routine ROP screening and as close as possible to 36 corrected weeks. The ERG luminance-response function will be recorded using different filters and background lighting to distinguish rod and cone responses. Conjunctival impression cytology (CIC) will be performed coincident with the ERG by taking a single sample from the bulbar conjunctiva, using a Millicell® filter.

All infants will be examined weekly for signs of vitamin A toxicity, including mucocutaneous lesions, bone and joint abnormalities and fullness of the anterior fontanelle. Weekly blood tests during the period of IM injections will include full blood count and liver function.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Additional Vitamin A Supplementation Improve Retinal Function and Conjunctival Health in Very Low Birthweight Infants?
Study Start Date : January 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: vitamin A Drug: Aquasol A
IM Aquasol A 10,000IU three times weekly
Other Name: vitamin A

Drug: aquasol A
10,000 IU three times weeks, by intramuscular injection
Other Name: vitamin A

Sham Comparator: sham injection Other: sham injection
sham injection

Primary Outcome Measures :
  1. retinal function at 36 corrected weeks [ Time Frame: 36 corrected weeks ]

Secondary Outcome Measures :
  1. plasma levels of vitamin A at birth, 7 and 28 days [ Time Frame: birth, 7 and 28 days ]
  2. hepatic stores of vitamin A at 36 corrected weeks [ Time Frame: 36 corrected weeks ]

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Ages Eligible for Study:   24 Hours to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infants born at < 32 completed weeks gestation and/or weighing < 1501 grams birth weight who have been admitted to either Princess Royal Maternity or Queen Mother's Hospital within the first 24 hours of life.

Exclusion Criteria:

  • Congenital ocular abnormality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417404

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United Kingdom
Queen Mother's Hospital
Glasgow, United Kingdom, G3 8SJ
Princess Royal Maternity
Glasgow, United Kingdom, G31 2ER
Sponsors and Collaborators
Glasgow Royal Infirmary
Chief Scientist Office of the Scottish Government
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Principal Investigator: Helen Mactier, MD Glasgow Royal Infirmary
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Responsible Party: Dr Fiona Graham, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT00417404    
Other Study ID Numbers: RNO50BO17
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: June 25, 2010
Last Verified: June 2010
Keywords provided by Glasgow Royal Infirmary:
vitamin A
vitamin A status
conjunctival health
Additional relevant MeSH terms:
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Retinopathy of Prematurity
Premature Birth
Birth Weight
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Retinal Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Body Weight
Vitamin A
Retinol palmitate
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents