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

NCT ID: NCT00692224

Last Updated: 2008-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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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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Conditions

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Neonatal Jaundice

Keywords

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neonatal jaundice zinc hyperbilirubinemia enterohepatic circulation bilirubin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

study group received zinc gluconate in a dose of 10 mg/day

Group Type ACTIVE_COMPARATOR

zinc gluconate

Intervention Type DRUG

zinc gluconate syrup - 10mg/day in two divided doses from day 2 to day 7 of life

2

placebo group received placebo which was identical in color, taste and appearance and packaged in similar looking bottles.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo was packed in similar looking bottles and ad similar taste as zinc gluconate drug

Interventions

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zinc gluconate

zinc gluconate syrup - 10mg/day in two divided doses from day 2 to day 7 of life

Intervention Type DRUG

placebo

placebo was packed in similar looking bottles and ad similar taste as zinc gluconate drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Hours

Maximum Eligible Age

30 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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All India Institute of medical sciences

Principal Investigators

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Nidhi Rana, M.D

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

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All India Institute Of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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A-68:12/08/2005

Identifier Type: -

Identifier Source: org_study_id