MedTrace Logo

Effect of Lactoferrin on Polio Seroconversion

NCT04432935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2023-08-16

No results posted yet for this study

Summary

A massive decline in cases of poliomyelitis was observed worldwide since 1988; however its transmission continues in Pakistan and Afghanistan. In 2017, a total of 17 cases were reported from these countries, which represent approximately half of the cases reported in 2016. This achievement was made possible by large scale use of oral polio vaccine (OPV) and inactivated polio vaccine (IPV). Despite vigorous efforts to end poliovirus transmission in endemic areas, several challenges including illiteracy, poverty, malnutrition, difficulty to access health and immunization services adversely affect the effectiveness of the polio eradication efforts. Innovations are thus needed to accomplish the goal of eradication as due to limited funding, the sustainability of a program becomes questionable. The aim of this study is to assess the effectiveness of lactoferrin in increasing mucosal and serum immunity in children following administration of poliovirus vaccines.

Conditions

  • Poliomyelitis

Interventions

DIETARY_SUPPLEMENT

Bovine Lactoferrin

Lactoferrin is a nutritional supplement which was first discovered in bovine milk which was later isolated in human milk as the second most abundant protein; with high levels found in colostrum. The use of bovine Lactoferrin in children is generally recognized as safe by the US Food and Drug Administration.

OTHER

Placebo Glucon D

This group will be given 100mg Glucon-D (99.4% glucose) which will be similar in shape, color to the bLF.

Sponsors & Collaborators

Principal Investigators

  • Sajid Soofi, MBBS, FCPS · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
23 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Companies

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 NCT04432935 on ClinicalTrials.gov