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The potential toxicity to neonates of multivitamin preparations used in parenteral nutrition
Insights
This study found that neither MVI-Concentrate nor MVI-Pediatric caused significant diuresis in very low birth weight infants. However, MVI-Pediatric may lead to high vitamin E levels, and propylene glycol (PG) can reach significant blood levels.
Area of Science:
- Neonatalogy
- Pediatric Nutrition
- Clinical Pharmacology
Background:
- Very low birth weight infants require specialized nutritional support, including intravenous nutrition (ivn).
- Multivitamin preparations are often administered as part of ivn, but their safety profiles require careful evaluation in this vulnerable population.
- Propylene glycol (PG) and mannitol are common excipients in pediatric formulations, with potential implications for fluid and electrolyte balance.
Purpose of the Study:
- To compare the effects of MVI-Concentrate (containing PG) and MVI-Pediatric (containing mannitol) on fluid balance and biochemical parameters in very low birth weight infants receiving ivn.
- To assess the impact of these formulations on vitamin E levels and the potential for accumulation of PG.
- To determine if either formulation is associated with clinically significant diuresis.
Main Methods:
- A comparative study involving two groups of infants weighing <1500 g at birth.
- One group received MVI-Concentrate with PG; the other received MVI-Pediatric with mannitol as part of their ivn.
- Serial measurements of serum and urine osmolality, PG, blood-urea-nitrogen, creatinine, electrolytes, glucose, and vitamin E levels were performed.
- Daily monitoring of weight, urine output, and fluid intake.
Main Results:
- No significant differences in baseline characteristics (birth weight, gestational age, sex, age) were observed between the groups.
- Neither MVI-Concentrate nor MVI-Pediatric administration resulted in clinically significant diuresis.
- Infants receiving MVI-Pediatric showed potentially high vitamin E levels, and infants receiving PG exhibited significant blood PG concentrations.
Conclusions:
- MVI-Concentrate and MVI-Pediatric do not appear to cause significant diuresis in very low birth weight infants.
- Careful monitoring of vitamin E levels is recommended when using MVI-Pediatric in this population.
- The use of PG-containing formulations requires attention to potential PG accumulation in very low birth weight infants.
Abstract:
This study compares two groups of infants weighing less than 1500 g at birth. In the propylene glycol (PG) group, 30 infants received MVI-Concentrate containing 300 mg of PG daily with their intravenous nutrition (ivn), and vitamin E, 50 mg/week by intramuscular injection. In the mannitol group, 30 infants received MVI-Pediatric (containing 245 mg mannitol), 65% of a vial/day. Serum and urine osmolality, serum PG, blood-urea-nitrogen, creatinine, sodium, and glucose were measured on days 0, 2, 5, 12, 19, 26, 33 and 40 of ivn. Weight, urine output, and fluid intake were measured daily. Vitamin E levels were measured on days 5, 26, and 33 of ivn. There were no significant differences between the groups in birth weight, gestational age, sex, age, or weight at start of ivn. Our results indicated that neither MVI-Concentrate nor MVI-Pediatric was associated with a clinically significant diuresis. MVI-Pediatric, 65% of a vial/day, may produce higher than desirable blood levels of vitamin E, and use of drugs containing PG can produce significant blood levels of PG, in very low birth weight infants.