Status:
UNKNOWN
Inflammation, Iron Deficiency and Anaemia Study 1
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
University of Oxford
Conditions:
Anemia
Eligibility:
All Genders
6-24 years
Brief Summary
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 this f...
Detailed Description
Aim 1: Hypothesis 1: 'Minor' but persistent infections of the respiratory tract, skin, mouth, and gut cause chronic elevation of hepcidin levels and other markers of infection including CRP. Researc...
Eligibility Criteria
Inclusion
- 1)Male or female children ages 6-8 months at the time of study enrolment.
- 2)Signed or fingerprinted or personally marked written informed consent obtained from their parent/guardian.
- 3)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
- 1\) Acute illness
- 2\) Fever (for eligibility purpose defined as a body temperature greater than 37.5°C) if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
- 3)Vaccination less than 7 days prior to study enrollment.
- 4)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).
- 5)Administration of systemic antibiotic treatment within 3 days prior to study enrolment.
- 6)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).
- 7)Any history of maternal human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
- 8)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.
- 9)Participation in another MRC study.
Key Trial Info
Start Date :
May 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04097639
Start Date
May 7 2019
End Date
November 1 2021
Last Update
January 9 2020
Active Locations (1)
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1
Keneba Field Station
Keneba, The Gambia