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

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00692224
First received: June 5, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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
Neonatal Jaundice
Drug: zinc gluconate
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
Active Comparator: 1
study group received zinc gluconate in a dose of 10 mg/day
Drug: zinc gluconate
zinc gluconate syrup - 10mg/day in two divided doses from day 2 to day 7 of life
Placebo Comparator: 2
placebo group received placebo which was identical in color, taste and appearance and packaged in similar looking bottles.
Drug: placebo
placebo was packed in similar looking bottles and ad similar taste as zinc gluconate drug

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.

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  Eligibility

Ages Eligible for Study:   up to 30 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00692224

Locations
India
All India Institute Of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Nidhi Rana, M.D All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Nidhi Rana, All India Institute of medical sciences
ClinicalTrials.gov Identifier: NCT00692224     History of Changes
Other Study ID Numbers: A-68:12/08/2005
Study First Received: June 5, 2008
Last Updated: June 5, 2008
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
neonatal jaundice
zinc
hyperbilirubinemia
enterohepatic circulation
bilirubin

Additional relevant MeSH terms:
Hyperbilirubinemia
Jaundice
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014