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

NCT00692224 | Completed Phase 1 DMC

• 1 other identifier: A-68:12/08/2005
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

neonatal jaundice; zinc; hyperbilirubinemia; enterohepatic circulation; bilirubin

Outcome Measures

Primary Outcomes (1)

• 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.

  first week of life

Secondary Outcomes (2)

• The mean total serum bilirubin level at 72±12 hours of age.

  first two weeks of life

• The proportion of infants requiring phototherapy and the duration thereof

  first two weeks of life

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: zinc gluconate

2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

zinc gluconate DRUG

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

1

placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Hours - 30 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates born at ≥35 weeks gestation and with total serum bilirubin ≥ 6 mg/dL at 24±6 h of life.

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute Of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nidhi Rana, M.D

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 6, 2008
• Study Start: October 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: June 6, 2008

Record last verified: 2008-06

Locations

IN (1)