An observational study in Iron Deficiency, Anaemia in Children, sponsored by London School of Hygiene and Tropical Medicine. Status unknown at 1 site in Gambia. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2020-01-09.
Sponsored by London School of Hygiene and Tropical Medicine · Observational
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:
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:
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.
386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 77 observational studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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sick children with fever
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inclusion criteria (one from the list below): 1. Positive leukocytes, positive nitrites on dipstick 2. Negative leukocytes, Positive nitrites on dipstick 3. Positive leukocytes, negative nitrites, plus bacteriuria on microscopy 4. Positive leukocytes, negative nitrities plus no bacteriuria, only pyuria on microscopy PLUS clinical features e.g. fever, pain on urination, offensive smelling urine. Exclusion criteria (one from the list below): 1. No evidence of UTI on dipstick
Procedure: blood sampling
Inclusion criteria (one from the list below):: 1. Evidence of nasal discharge AND/OR 2. Inflammation throat/ tonsils on direct examination AND/OR 3. Inflammation of middle or outer ear on direct examination 4. History of fever AND history of stridor/ barking cough 5. History of fever AND lymphadenopathy AND/ OR URTI symptoms i.e sore throat/ cough Exclusion criteria (one from the list below):: 1. Foreign body inserted in either nose/ ear 2. Traumatic perforation of ear drum 3. Allergic rhinitis i.e. good contact history 4. Evidence of LRTI
Procedure: blood sampling
Inclusion criteria (one from the list below): 1. Focal signs on auscultation of the chest i.e crepitations/ wheeze/ reduced air entry 2. Fever \> 38.5C AND chest recessions AND/OR raised respiratory rate 3. Radiological evidence of LRTI Exclusion criteria (one from the list below): 1. Positive malaria test OR suspicion of metabolic acidosis causing tachypnoea and fever
Procedure: blood sampling
Inclusion criteria (one from the list below): 1. Abrupt onset of 3 or more loose/liquid stools/ day 2. Ova, cysts, parasites identified on stool microscopy PLUS symptomatic diarrhoea,and/ or fever and/or vomiting 3. Fever AND vomiting WITHOUT other source of fever i.e UTI/LRTI/URTI Exclusion criteria (one from the list below): 1. Normal breast milk stool 2. Neurological cause of vomiting
Procedure: blood sampling
observational study and no intervention will be given. only blood samples collected and treated with iron supplements
Change in Serum hepcidin from baseline to day 14
Time frame: Day 14
Change in Clinical score of site and severity of infection and inflammation from baseline to day 14
Time frame: Day 14
serum iron levels
Increase in serum iron levels above baseline following an oral ferrous fumarate dose as a measure of iron absorption
Time frame: Day 0, 3, 7 & 14
Erythropoietin
Time frame: Day 0, 3, 7 & 14
Erythroferrone
Time frame: Day 0, 3, 7 & 14
Started Jul 2019 (actual). Primary completion is estimated for Jan 2023, 42 months after the start.
Of 24 observational studies under Iron Deficiencies, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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