Efficacy of fat-soluble vitamin supplementation in infants with biliary atresia

Pediatrics. 2012 Sep;130(3):e607-14. doi: 10.1542/peds.2011-1423. Epub 2012 Aug 13.


Objective: Cholestasis predisposes to fat-soluble vitamin (FSV) deficiencies. A liquid multiple FSV preparation made with tocopheryl polyethylene glycol-1000 succinate (TPGS) is frequently used in infants with biliary atresia (BA) because of ease of administration and presumed efficacy. In this prospective multicenter study, we assessed the prevalence of FSV deficiency in infants with BA who received this FSV/TPGS preparation.

Methods: Infants received FSV/TPGS coadministered with additional vitamin K as routine clinical care in a randomized double-blinded, placebo-controlled trial of corticosteroid therapy after hepatoportoenterostomy (HPE) for BA (identifier NCT 00294684). Levels of FSV, retinol binding protein, total serum lipids, and total bilirubin (TB) were measured 1, 3, and 6 months after HPE.

Results: Ninety-two infants with BA were enrolled in this study. Biochemical evidence of FSV insufficiency was common at all time points for vitamin A (29%-36% of patients), vitamin D (21%-37%), vitamin K (10%-22%), and vitamin E (16%-18%). Vitamin levels were inversely correlated with serum TB levels. Biochemical FSV insufficiency was much more common (15%-100% for the different vitamins) in infants whose TB was ≥2 mg/dL. At 3 and 6 months post HPE, only 3 of 24 and 0 of 23 infants, respectively, with TB >2 mg/dL were sufficient in all FSV.

Conclusions: Biochemical FSV insufficiency is commonly observed in infants with BA and persistent cholestasis despite administration of a TPGS containing liquid multiple FSV preparation. Individual vitamin supplementation and careful monitoring are warranted in infants with BA, especially those with TB >2 mg/dL.

Trial registration: ClinicalTrials.gov NCT00294684.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Avitaminosis / blood
  • Avitaminosis / drug therapy*
  • Avitaminosis / etiology
  • Biliary Atresia / complications*
  • Biliary Atresia / surgery
  • Bilirubin / blood
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Male
  • Polyethylene Glycols / therapeutic use
  • Portoenterostomy, Hepatic
  • Postoperative Care
  • Retinol-Binding Proteins / analysis
  • Vitamin A / blood
  • Vitamin D / analogs & derivatives
  • Vitamin D / blood
  • Vitamin E / analogs & derivatives*
  • Vitamin E / blood
  • Vitamin E / therapeutic use
  • Vitamin K / therapeutic use*
  • alpha-Tocopherol / blood


  • Retinol-Binding Proteins
  • Vitamin A
  • Vitamin K
  • Vitamin D
  • Vitamin E
  • Polyethylene Glycols
  • 25-hydroxyvitamin D
  • alpha-Tocopherol
  • tocophersolan
  • Bilirubin

Associated data

  • ClinicalTrials.gov/NCT00294684

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