Vitamin A and Very Low Birthweight Babies (VitAL)

This study has been completed.
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by:
Glasgow Royal Infirmary
ClinicalTrials.gov Identifier:
NCT00417404
First received: December 29, 2006
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Preterm Birth
Retinopathy of Prematurity
Drug: Aquasol A
Drug: aquasol A
Other: sham injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Additional Vitamin A Supplementation Improve Retinal Function and Conjunctival Health in Very Low Birthweight Infants?

Resource links provided by NLM:


Further study details as provided by Glasgow Royal Infirmary:

Primary Outcome Measures:
  • retinal function at 36 corrected weeks [ Time Frame: 36 corrected weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma levels of vitamin A at birth, 7 and 28 days [ Time Frame: birth, 7 and 28 days ] [ Designated as safety issue: Yes ]
  • hepatic stores of vitamin A at 36 corrected weeks [ Time Frame: 36 corrected weeks ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417404

Locations
United Kingdom
Princess Royal Maternity
Glasgow, United Kingdom, G31 2ER
Queen Mother's Hospital
Glasgow, United Kingdom, G3 8SJ
Sponsors and Collaborators
Glasgow Royal Infirmary
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Helen Mactier, MD Glasgow Royal Infirmary
  More Information

No publications provided

Responsible Party: Dr Fiona Graham, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT00417404     History of Changes
Other Study ID Numbers: RNO50BO17, CZB/4/316
Study First Received: December 29, 2006
Last Updated: June 24, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Glasgow Royal Infirmary:
preterm
nutrition
vitamin A
electroretinogram
conjunctiva
vitamin A status
conjunctival health

Additional relevant MeSH terms:
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Retinal Diseases
Retinol palmitate
Vitamin A
Vitamins
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014