CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 468 enrolled
Drug / intervention
Bovine Lactoferrin +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04432935
NCT04432935N/ACompleted

Effect of Bovine Lactoferrin on Seroconversion Following Polio Vaccine Administration in Children: A Randomized Control Trial

Aga Khan University·interventional·Posted Jun 16, 2020·Updated Aug 16, 2023

In Brief

A clinical study evaluating Bovine Lactoferrin and Placebo Glucon D for Poliomyelitis. Completed, enrolled 468 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis
CountriesPakistan

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 16, 2020
Enrollment StartOct 1, 2020
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.0 years ago

Interventions

Bovine Lactoferrindietary

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.

Placebo Glucon Dother

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