Status:
UNKNOWN
An Observational Study Designed to Elucidate the Pathways by Which Inflammation Contributes to Anaemia in Sick Rural African Children From 6 Months to 36 Months
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
University of Oxford
Conditions:
Iron Deficiency, Anaemia in Children
Eligibility:
All Genders
6-36 years
Brief Summary
The Investigator have previously shown that hepcidin is up-regulated even by low levels of inflammation and, according to our prior stable isotope studies, is predicted to block iron absorption. In th...
Detailed Description
Aim 1: To test whether non-malarial infections increase hepcidin levels and for how long in sick children (note that the investigator exclude malaria because the investigator and others have previousl...
Eligibility Criteria
Inclusion
- Male or female children ages 6-36 months
- Fever ( \> 37.5C) and/or signs of illness.
- Signed or fingerprinted or personally marked written informed consent obtained from their parent/guardian.
- Parent/guardian plans for subject to reside in study site area and are able and willing to adhere to all protocol visits and procedures.
Exclusion
- Critically unwell requiring stabilisation and transfer i.e. scores 3 on initial assessment
- Sickle cell disease
- Evidence of hookworm infection by stool microscopy
- Administration of immunosuppressants or other immune-modifying agents within 90 days prior to study IP administration (e.g., systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone for more than 14 days; topical steroids including inhaled and intranasal steroids are not exclusionary).
- Administration of systemic antibiotic treatment within 3 days prior to study enrolment.
- Any history of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, malnutrition\*, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease). \* Other than the exclusionary clinical diagnosis of malnutrition for all subjects, in children 2 to 5 years of age, malnutrition is also defined as a weight-for-height Z-score of less than -3 as per WHO reference standards.
- Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
- Any condition that in the opinion of the investigator might compromise the safety or well-being of the subject or compromise adherence to protocol procedures
- Participation in another MRC study
Key Trial Info
Start Date :
July 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04095884
Start Date
July 17 2019
End Date
April 1 2023
Last Update
January 9 2020
Active Locations (1)
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1
Keneba MRC Unit
West Kiang, City of Banjul, The Gambia, 0000