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Does vitamin C cause hemolysis in premature newborn infants? Results of a multicenter double-blind, randomized,
J Doyle1, H J Vreman, D K Stevenson
1Hospital for Sick Children, Women's College Hospital, and Mount Sinai Hospital Department of Pediatrics, University of Toronto, Ontario, Canada.
Insights
Vitamin C supplementation in premature infants did not increase hemolysis or bilirubin levels. This study found no evidence of harm from vitamin C in this vulnerable population.
Area of Science:
- Neonatal Medicine
- Nutritional Science
- Pediatric Research
Background:
- Premature neonates have unique nutritional needs and are susceptible to oxidative stress.
- The role of vitamin C in preventing hemolysis in premature infants requires further investigation.
Purpose of the Study:
- To evaluate the hypothesis that vitamin C supplementation in premature neonates is associated with hemolysis.
- To assess the safety and efficacy of vitamin C supplementation in premature infants.
Main Methods:
- A double-blind, randomized, controlled trial was conducted with premature neonates (birth weight 1000-1500 gm).
- Infants received either vitamin C (50 mg/day) or placebo for 14 days.
- Key outcome measures included corrected carboxyhemoglobin, hemolysis parameters, and bilirubin levels.
Main Results:
- Vitamin C levels were significantly higher in supplemented neonates on day 14.
- No significant differences were observed in corrected carboxyhemoglobin concentrations or other hemolysis parameters between groups.
- Bilirubin values were initially higher in controls, but this difference was not statistically significant after outlier exclusion.
Conclusions:
- Oral vitamin C supplementation in premature infants is not associated with increased erythrocyte destruction.
- The study found no evidence of increased hyperbilirubinemia or other morbidities related to vitamin C supplementation.
- Vitamin C appears to be safe for premature infants at the specified dosage.
Objective:
We tested the hypothesis that vitamin C supplementation of premature neonates is associated with hemolysis.
Study Design:
A double-blind, randomized, controlled trial of vitamin C supplementation (50 mg/day) was undertaken in premature neonates (birth weight, 1000 to 1500 gm). Infants were randomly assigned to receive vitamin C (Ce-Vi-Sol) (n = 32) or placebo (n = 24) for 14 days. Twenty-three subjects per group were required to detect a difference of 1 SD in corrected carboxyhemoglobin values (alpha = 0.05, beta = 0.10).
Results:
Day 14 vitamin C levels were lower in control subjects than in supplemented neonates (62 +/- 24 vs 125 +/- 62 micromol/L, p = 0.005). There was no difference in corrected blood carboxyhemoglogin concentrations (0.72 +/- 0.44 vs 0.72 +/- 0.23%; p = 0.95), other parameters of hemolysis, weight gain, blood sampled, presumed septic episodes, necrotizing enterocolitis, feeding intolerance, or transfusion. On day 14, bilirubin values were higher in control subjects than in the supplemented group (77 +/- 37 vs 55 +/- 33 micromol/L; p = 0.04). When a distant outlier in the nonsupplemented group was excluded (163 micromol/L), statistical significance was lost (73 +/- 32 vs 55 +/- 33 micromol/L; p = 0.09).
Conclusion:
Oral supplementation of premature infants with vitamin C is not associated with evidence of increased erythrocyte destruction, hyperbilirubinemia, or other morbidity.