Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
Condition: Neonatal Jaundice
MeSH terms: Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the effect of 10 mg of oral zinc given daily
      between days 2 and 7 of life to term or near term neonates with serum bilirubin levels of
      more than 6 mg/dL at 24 ± 6 hours of life on hyperbilirubinemia and phototherapy.
    

Detailed description: 
      Neonatal hyperbilirubinemia is a common problem occurring in nearly 5-25% neonates.Inhibition
      of enterohepatic circulation is one of the therapies being tried for neonatal jaundice.
      Studies have suggested that in a neonate, the postulated enterohepatic pathway is of a
      magnitude that could be significant in the overall body economy of bilirubin.Zinc has also
      been investigated for its role in decreasing the STB levels by inhibiting enterohepatic
      circulation. There have been animal studies which have investigated the role of zinc in
      decreasing the serum bilirubin levels. The mechanism proposed is that zinc salts precipitate
      Unconjugated bilirubin from unsaturated micellar solution of bile salts and consequently
      inhibit the enterohepatic circulation of bilirubin. This is the first study to evaluate the
      role of zinc in neonatal jaundice.

      Study Design: In this randomized placebo controlled clinical trial neonates born at ≥35 wk of
      gestation and with total serum bilirubin ≥6mg% were given either zinc gluconate (n = 148) or
      placebo (n = 146) in a dose of 10mg per day between days 2 and 7 of life. Jaundice was
      assessed clinically and total serum bilirubin estimated using spectrophotometry. Infants were
      followed up clinically until discharge and then again at day 7 of life. Hyperbilirubinemia
      was defined as total serum bilirubin ≥15mg%.

      Results: Incidence of hyperbilirubinemia was comparable in zinc and placebo groups (OR 0.95,
      95% CI 0.50-1.67, p=0.92). The requirement of phototherapy was similar in the two groups (OR
      0.81, 95% CI 0.41-1.61, p=0.55). The mean hours of phototherapy in the zinc group were also
      similar in the two groups (p=0.63). No significant difference with respect to mean levels of
      bilirubin (mg/dL) at 72±12 hours of age was observed in two groups(zinc 11.3±3.3,placebo
      11.5±3.8,p=0.63). No significant adverse effects of zinc were noted.

      Conclusion: Twice daily zinc administration in a dose of 10 mg/day does not reduce
      hyperbilirubinemia in at risk neonates in the first week of life.

      .
    

Intervention name(s): zinc gluconate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): zinc gluconate syrup - 10mg/day in two divided doses from day 2 to day 7 of life; placebo was packed in similar looking bottles and ad similar taste as zinc gluconate drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: neonatal jaundice; zinc; hyperbilirubinemia; enterohepatic circulation; bilirubin