Does additional vitamin A supplementation improve retinal function and conjunctival health in very low birth weight infants? - vitamin A and retinal function in low birth weight infants

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003402-29-GB

Enrollment

Registered

2005-09-26

Start date

2005-10-21

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presumed vitamin A deficiency in preterm infants

Interventions

Trade Name: Aquasol A Parenteral Product Name: Aquasol A Product Code: vitamin A Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants born at =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Congenital ocular abnormality

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To investigate the potential role of vitamin A in prevention of retinopathy of prematurity and to define optimal vitamin A intake for very low birth weight infants.;Main Objective: To assess both retinal function (by means of the ERG) and conjunctival health (by conjunctival impression cytology (CIC)) in VLBW infants randomised to receive supplemental vitamin A in intravenous fat emulsion as per current practice, or additional IM vitamin A, 10,000IU three time weekly for the first four weeks. ; Primary end point(s): Retinal function at 36 corrected weeks. This will be compared between supplemented and unsupplemented groups and correlated with plasma retinol, calculated total vitamin A intake and hepatic stores. In addition, CIC, plasma levels of vitamin A at birth, 7 and 28 days and hepatic stores at 36 corrected weeks will be compared between supplemented and unsupplemented groups and correlated with calculated total vitamin A intake, total period of parenteral nutrition, gestational age and birth weight. Clinical outcomes will be monitored including duration of in-patient stay, ventilatory support, requirement for supplemental oxygen and ROP.	—

Measure

Time frame

Secondary Objective: To investigate the potential role of vitamin A in prevention of retinopathy of prematurity and to define optimal vitamin A intake for very low birth weight infants.;Main Objective: To assess both retinal function (by means of the ERG) and conjunctival health (by conjunctival impression cytology (CIC)) in VLBW infants randomised to receive supplemental vitamin A in intravenous fat emulsion as per current practice, or additional IM vitamin A, 10,000IU three time weekly for the first four weeks. ; Primary end point(s): Retinal function at 36 corrected weeks. This will be compared between supplemented and unsupplemented groups and correlated with plasma retinol, calculated total vitamin A intake and hepatic stores. In addition, CIC, plasma levels of vitamin A at birth, 7 and 28 days and hepatic stores at 36 corrected weeks will be compared between supplemented and unsupplemented groups and correlated with calculated total vitamin A intake, total period of parenteral nutrition, gestational age and birth weight. Clinical outcomes will be monitored including duration of in-patient stay, ventilatory support, requirement for supplemental oxygen and ROP.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026