Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
This study has been completed.
Study NCT00692224   Information provided by All India Institute of Medical Sciences, New Delhi
First Received: June 5, 2008   No Changes Posted

June 5, 2008
June 5, 2008
October 2005
October 2006   (final data collection date for primary outcome measure)
Incidence of hyperbilirubinemia defined as total serum bilirubin more than or equal to 15 mg/dL at anytime between days 2 and 7 of life. [ Time Frame: first week of life ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • The mean total serum bilirubin level at 72±12 hours of age. [ Time Frame: first two weeks of life ] [ Designated as safety issue: Yes ]
  • The proportion of infants requiring phototherapy and the duration thereof [ Time Frame: first two weeks of life ] [ Designated as safety issue: Yes ]
Same as current
 
Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
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

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.

.

Phase I, Phase II
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Neonatal Jaundice
  • Drug: zinc gluconate
  • Drug: placebo
  • Active Comparator: study group received zinc gluconate in a dose of 10 mg/day
  • Placebo Comparator: placebo group received placebo which was identical in color, taste and appearance and packaged in similar looking bottles.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
294
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
up to 30 Hours
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00692224
Nidhi Rana, All India Institute of medical sciences
A-68:12/08/2005
All India Institute of Medical Sciences, New Delhi
 
Principal Investigator: Nidhi Rana, M.D All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP