Status:
COMPLETED
Effect of Lactoferrin on Polio Seroconversion
Lead Sponsor:
Aga Khan University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Poliomyelitis
Eligibility:
All Genders
1-23 years
Phase:
NA
Brief 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 cou...
Detailed Description
Lactoferrin 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. Evidence suggests that Lactoferrin enha...
Eligibility Criteria
Inclusion
- Pregnant females aged 18 to 45 years with no underlying complications or co-morbidities
- Residence less than 30 kms away from the study clinic and have resided there for at least 1 year. Family MUST indicate that they will not move from their current residence for the 5 months after birth of the child (study period)
- Healthy singleton full-term births born to these mothers, regardless of birth weight and an APGAR score of 7 or higher 5 minutes after delivery with no underlying complication (randomization will take place at this stage)
Exclusion
- Females with health issues and high risk pregnancies
- Neonates presenting with any morbidities and congenital anomalies will be excluded from the study
- Preterm birth (\<37 weeks of gestation)
- Immunodeficiency disorder in immediate family member
- Parents refusing to consent
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT04432935
Start Date
October 1 2020
End Date
June 30 2022
Last Update
August 16 2023
Active Locations (1)
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1
Kharadar Campus, Aga Khan University Hospital
Karachi, Pakistan, 74800