A clinical trial to study the beneficial effects of zinc sulfate in reducing the adverse effects of acute inflammation and calprotectin activity in neonatal sepsis.

Effects of zinc supplementation on serum calprotectin level and acute inflammatory response in neonatal sepsis â?? a double blind randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002517

Enrollment

134

Registered

2012-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Neonatal sepsis

Interventions

Intervention1: Zinc sulfate along with routine antibiotic treatment: Dose - 15mg/day Mode of administration - oral Till discharge from hospital Control Intervention1: Placebo along with routine antibi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 2. Clinically diagnosed sepsis with two positive sepsis screening tests (mESR, CRP) 3. No antibiotic treatment before enrollment in the study

Exclusion criteria

Exclusion criteria: 1. Major surgical procedures 2. Maternal history of antibiotic therapy before delivery 3. Apgar score <6 at 5 minutes

Design outcomes

Primary

Measure	Time frame
1. Decrease in mortality 2. Decrease in serum calprotectin level 3. Reduced adverse effects of acute inflammatory responseTimepoint: 10 days	—

Secondary

Measure	Time frame
1. Associated complications (DIC, shock) 2. Duration of hospital stay 3. Requirement of antibioticsTimepoint: 10 days	—

Countries

India

Contacts

Public ContactDr Vishnu Bhat

JIPMER

drvishnubhat@yahoo.com09842351282

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026