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Absorption of intramuscular vitamin E in premature babies. Italian Collaborative Group on Preterm Delivery
Insights
The olive oil formulation of vitamin E (alpha-tocopherol) used in Italy provides significantly lower therapeutic levels in preterm infants compared to aqueous solutions. This intramuscular vitamin E study highlights bioavailability issues with the current olive oil preparation.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Biochemistry
Background:
- Vitamin E (alpha-tocopherol) is crucial for preventing serious conditions in preterm infants, including intraventricular hemorrhage and bronchopulmonary dysplasia.
- Intramuscular formulations are widely used in neonatal intensive care units, but their efficacy can vary.
- Current clinical practice in Italy relies on an olive oil solution, while other countries use different formulations.
Purpose of the Study:
- To compare the bioavailability and therapeutic levels of intramuscular vitamin E (alpha-tocopherol) from an olive oil solution versus a colloidal aqueous solution in preterm infants.
- To assess the impact of different vitamin E formulations on plasma concentrations in neonates.
Main Methods:
- A randomized study involving 44 preterm infants (gestation < 32 weeks, weight 670-1800 g) allocated to receive either an olive oil or a colloidal aqueous solution of vitamin E.
- Intramuscular vitamin E (20 mg/kg) administered on three consecutive days starting within 8 hours of birth.
- Blood, plasma, red blood cells, and milk samples collected up to day six; clinical data gathered until discharge.
Main Results:
- Plasma concentrations of vitamin E (free tocopherol) were approximately six times lower with the olive oil solution compared to the colloidal aqueous solution.
- Plasma vitamin E levels did not increase above baseline after administration of the olive oil preparation.
- The acetate ester of vitamin E, measured after the colloidal aqueous solution, reached a peak plasma concentration of 1.01 mg/dl at 72 hours.
Conclusions:
- The widely used intramuscular olive oil formulation of vitamin E in Italy demonstrates poor bioavailability and fails to achieve suggested therapeutic levels in preterm infants.
- Findings suggest a need to re-evaluate current clinical practices regarding vitamin E prophylaxis in Italy.
- Alternative, more bioavailable vitamin E formulations should be considered for neonatal care to ensure adequate therapeutic levels.
Abstract:
Vitamin E (alpha-toxopherol) is widely used, at different dosages and schedules and in different formulations, in neonatal intensive care units to prevent intraventricular hemorrhage, retrolental fibroplasia, bronchopulmonary dysplasia and hemolytic anemia of preterm infants. As part of a wider project to assess the effect of vitamin E, the present study was designed to determine whether the only intramuscular formulation available today in Italy and in other European countries (olive oil solution), and widely used in all Italian neonatal intensive care units according to a standard schedule, achieves and maintains suggested therapeutic levels, compared to the colloidal aqueous solution used in clinical trials in England and Canada, which contained the acetate ester of alpha-tocopherol and as used in the USA, which contained the free tocopherol, but is not yet available in Italy. Forty-four babies, of less than 32 weeks' gestation, 670-1,800 g birth weight, were randomly allocated to one of the two formulations. We gave 20 mg/kg of vitamin E intramuscularly on 3 consecutive days starting within 8 h of birth (day 0), 24 and 48 h later (days 1 and 2). Blood, plasma, red blood cells after transfusions and milk were sampled up to the sixth day of life. Clinical data were collected up to discharge from the neonatal intensive care unit. Plasma concentrations of vitamin E (free tocopherol) averaged 1.1 at 24 h and 3.3 mg/dl at 72 h after the colloidal aqueous solution, and were about 6 times lower after the oil solution. Plasma vitamin E levels did not rise above baseline after injection of the olive oil preparation. The acetate ester of vitamin E was measured only after use of the colloidal aqueous preparation, and the highest plasma concentration averaged 1.01 mg/dl 72 h after injection. These findings have far-reaching implications related to the current clinical practice in Italy of prophylaxis with intramuscular vitamin E, using the scantily bioavailable olive oil formulation currently on the market.