Iron Deficiency, Anaemia in Children Clinical Trial
Official title:
An Observational Trial Designed to Elucidate the Pathways by Which Inflammation Contributes to Anaemia in Sick Rural African Children From 6 Months to 36 Months
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 this follow-up observational study, the investigator aim to characterise the
relationship between infections, acute inflammation, hepcidin and iron iron deficiency
anaemia in rural African children. The Investigator will study 200 sick children (6-36 months
of age) living in the rural region of West Kiang.
The Investigator will:
1. Recruit 50 sick febrile children in each of 4 categories; Upper Respiratory tract
infections, Lower respiratory tract infections (pneumonia), Urinary tract infections,
gastroenteritis.
2. Assess iron absorption and its relationship to iron and anaemia status, inflammation,
EPO, erythroferrone and hepcidin.
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 previously examined the effect of malaria).
Hypothesis 1: On day 0, 3 and 7 of acute illness, hepcidin will be higher when compared to
levels in well children. On Day 14 iron absorption and hepcidin levels will have returned to
baseline.
Research Question 1: What affect do non-malarial infections (upper respiratory tract
infections, lower respiratory tract infections, urinary tract infections and gastroenteritis)
have on hepcidin levels and how long does this effect last?
Aim 2: To retest our existing hepcidin threshold for discriminating iron absorbers from
non-absorbers by repeating our prior ROC analysis based on a much larger sample.
Hypothesis: On day 0, 3 and 7 of acute illness, iron absorption will be lower. On Day 14,
iron absorption will be equivalent to iron absorption in well children. Note that the
Hepcidin levels and iron absorption data obtained in this study will be compared with the
results obtained from similarly aged children in IDeA Study 1 (SCC 1664). Also note that The
investigator anticipate that most of the children enrolled in this study will have a
base-line level of anaemia (eg Hgb<11g/dL).
Research Question: What is the relationship between hepcidin and oral iron absorption in
acute illness and convalescence and how does this differ from the relationship in well
children?
Aim 3: To examine EPO synthesis and EPO resistance in children with acute non-malarial
infections?
Hypotheses:
1. Children with acute non-malaria infections will have both acute and chronic anaemia of
inflammation.
2. EPO is increased during acute infection.
Research Question: Is there decreased EPO synthesis and/or increased EPO resistance in
children with acute non-malarial infections living in rural Gambia?
Aim 4: To examine erythroferrone in children with acute non-malarial infections leaving in
rural Gambia.
Hypothesis: First The investigator will conduct a hypothesis-free exploratory analysis to
assess whether erythroferrone behaves as predicted based upon mouse models (ie up-regulated
by stress erythropoiesis and inversely related to hepcidin). The investigator additionally
hypothesize that there may be a vicious cycle initiated by inflammation and then perpetuated
by the consequent low levels of (iron-restricted) erythropoiesis, leading to low
erythroferrone and loss of hepcidin suppression.
Research Question: What is the relationship between erythroferrone, iron status,
inflammation, hepcidin, EPO and CRP in anaemic and non-anaemic children living in rural
Gambia? This is an observational study of 200 sick children who will be recruited at the
Keneba clinic. Each child will be seen four times (at day 0, 3, 7 14).
200 subjects aged 6 -36m brought to Keneba clinic with an acute illness. 50 patients from
each category: Upper respiratory tract infections (including ear, nose and throat
infections), Lower respiratory tract infections, urinary tract infections and
gastroenteritis.
;
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