Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

NCT05311540 | Completed Phase 4

• 1 other identifier: ZincVLBW
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

• Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.
• Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life.
• Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.
• There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants.
• Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

Conditions

Preterm Infant; Effect of Drugs; Zinc Deficiency Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of feeding intolerance

  through study completion, an average of 6 months

Secondary Outcomes (6)

• Duration of hospitalization

  through study completion, an average of 6 months

• Number of participants with necrotising enterocolitis (stage≥2)

  through study completion, an average of 6 months

• Incidence of mortality

  through study completion, an average of 6 months

• Number of participants with late onset sepsis

  through study completion, an average of 6 months

• Number of participants with retinopathy of prematurity

  through study completion, an average of 6 months

Study Arms (2)

Zinc intervention

EXPERIMENTAL

9 mg/day Zinc suspension via og tube along with the routinely used standard multivitamin product containing 3 mg daily dose of Zn, started on day 7 until discharge from hospital

Drug: Zinc Sulfate

Control

NO INTERVENTION

These infants received only standard commercial multivitamin product containing 3 mg daily dose of Zn

Interventions

Zinc Sulfate DRUG

Zinc intervention

Eligibility Criteria

• Age: 7 Days - 9 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \< 32 weeks gestational age and/or \<1500 gr birth weight
• Born in the study hospital
• Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient

You may not qualify if:

• Major congenital malformations and/or critical congenital heart defects
• Born in another hospital
• Severe birth asphyxia
• Severe sepsis
• Previous early-onset NEC history
• Infants on the intervention arm who did not continue Zinc supplementation during the study period
• Hemodynamically unstability
• Infants nil per os
• No consent from the family
• Death before the 7th day of life

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (1)

Izmir Democracy University Faculty of Medicine

Izmir, 35290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: An independent physician not involved in the study conducted the random assignment process. The investigators who were blinded to the randomisation process closely followed up the enrolled infants for any evidence of feeding intolerance and/or NEC, late-onset sepsis (LOS), bronchopulmonary dysplasia (BPD), hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP) along with other possible neonatal morbidities and signs of toxicity or side effects (adverse events)
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: April 5, 2022
• Study Start: March 14, 2014
• Primary Completion: March 2, 2015
• Study Completion: April 20, 2015
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)