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

NCT00692224 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2008-06-06

No results posted yet for this study

Summary

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.

Conditions

  • Neonatal Jaundice

Interventions

DRUG

zinc gluconate

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

DRUG

placebo

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

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Nidhi Rana, M.D · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Hours
Max Age
30 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00692224 on ClinicalTrials.gov