Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
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.
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.

 .
Inclusion Criteria:

 -  Neonates born at ≥35 weeks gestation and with total serum bilirubin ≥ 6 mg/dL at 24±6
 h of life.

 Exclusion Criteria:

 -  Rh incompatibility

 -  Those given exchange transfusion/ phototherapy within 24 h of age.

 -  Major gross congenital anomaly

 -  Anticipated to require neonatal intensive care or required neonatal intensive care for
 more than 24 h.

 -  Systemic sepsis