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Sponsored by: |
All India Institute of Medical Sciences, New Delhi |
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Information provided by: | All India Institute of Medical Sciences, New Delhi |
ClinicalTrials.gov Identifier: | NCT00692224 |
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.
Condition | Intervention | Phase |
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Neonatal Jaundice |
Drug: zinc gluconate Drug: placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect 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 |
Enrollment: | 294 |
Study Start Date: | October 2005 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
study group received zinc gluconate in a dose of 10 mg/day
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Drug: zinc gluconate
zinc gluconate syrup - 10mg/day in two divided doses from day 2 to day 7 of life
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2: Placebo Comparator
placebo group received placebo which was identical in color, taste and appearance and packaged in similar looking bottles.
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Drug: placebo
placebo was packed in similar looking bottles and ad similar taste as zinc gluconate drug
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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.
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Ages Eligible for Study: | up to 30 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Delhi | |
All India Institute Of Medical Sciences | |
New Delhi, Delhi, India, 110029 |
Principal Investigator: | Nidhi Rana, M.D | All India Institute of Medical Sciences, New Delhi |
Responsible Party: | All India Institute of medical sciences ( Nidhi Rana ) |
Study ID Numbers: | A-68:12/08/2005 |
Study First Received: | June 5, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00692224 |
Health Authority: | India: Institutional Review Board |
neonatal jaundice zinc hyperbilirubinemia enterohepatic circulation bilirubin |
Signs and Symptoms Hyperbilirubinemia Zinc Infant, Newborn, Diseases |
Bilirubin Jaundice, Neonatal Hyperbilirubinemia, Neonatal Jaundice |
Skin Manifestations Pathologic Processes Growth Substances Physiological Effects of Drugs |
Trace Elements Micronutrients Pharmacologic Actions |