The effect of Zinc on Hyperbilirubinemia of healthy and normal newborns, a clinical trial

Evaluate the effect of Zinc on Hyperbilirubinemia in newborn babies in Zanjan

Clinical trial with control group, parallel group, double blinded, randomized

In this double-blind, randomized clinical trial, 112 healthy newborns with physiologic jaundice were equally divided into two groups receiving zinc and placebo. Each day, 10 mg of zinc (5 cc of syrup) was administered to the case group and also 5 cc of placebo was administered to the control group and the total bilirubin levels of the second, third, fourth and fifth day and duration of hospitalization and phototherapy were compared. Blinded people: Participant- Care provider

Participants:Healthy children with jaundice admitted to the neonatal ward Inclusion criteria: term infants; breast-feeding; jaundice; photo-therapy; serum bilirubin 15-20 mg / dL; age of 3 to 7 days; using no other drug Exclusion criteria: recent weight loss; infection; hemolytic disease; oral intolerance; congenital birth defects; gastrointestinal anomalies; parental dissatisfaction for participation in the study; need for ventilators; need for blood transfusion

Intervention group: Patients in the intervention group will receive 5 mg zinc (2.5 ml) of 10 mg per 5 ml Zinc Sulfate syrup produced by Donya-ye-Behdasht company twice a day from admission day until discharging from hospital. Control group: Patients in the control group will receive 2.5 ml of placebo syrup twice a day from admission day until discharging from hospital, which producted in the Faculty of Pharmacy, Zanjan University of Medical Sciences, completely similar to the main drug.

Serum total bilirubin in hospitalization days and hospitalization days

Zanjan University of Medical Sciences, vice chancellor for research

Block randomization is done. Patients are randomly assigned to one of the two intervention and placebo groups. The randomization unit is individual. Random number table is used. The random number table contains numbers from 1 to 112 in and we will read these numbers from up to down and we will write the succession. Then we will give Zinc sulfate to numbers 1 to 56 and Placebo to numbers 57 to 112. Then for hiding the sequence we will use sealed, opaque envelopes. Every one who will enter our study will choose one envelope which has one number of the random number table in it and his group will be defined.

drug packs are marked by the main investigator with two signs A or B. Medication packs are delivered to the care provider with signs A or B. The care provider and the participant are unaware of the contents of the A or B envelopes. After the end of the study, specific intervention of each patient would be explained to him. A contains zinc sulfate and B contains placebo.