An observational study in Anemia, sponsored by London School of Hygiene and Tropical Medicine. Status unknown at 1 site in Gambia. Open to participants aged 6 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-09.
Sponsored by London School of Hygiene and Tropical Medicine · Observational
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, investigator aim to elucidate the potential drivers of this low-grade inflammation and to recalibrate the relationship between hepcidin and iron absorption using a more direct measure of absorption than the stable isotope method which measures the net of absorption and utilization. Investigator will study 120 ostensibly well children (6-24m) living in the rural region of West Kiang.
Investigator will:
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.
Research Question 1: What is the relationship between each of the following: CRP, hepcidin, clinical score of skin infections; clinical score of oral health; clinical score of respiratory infections; and systemic markers of gut damage and bacterial translocation (serum EndoCAB and iFABP) and stool markers of inflammation (calprotectin, REG1b and lipocalin2).
Hypothesis 2: Respiratory infections and airway inflammation are the most common cause of low grade inflammation.
Research Question 2: What is the most common source(s) of persistent low-grade inflammation in apparently well children living in rural Gambia.
Aim 2:
Hypothesis: Hepcidin levels above 5.5ng/ml block oral iron absorption.
Research Question: What is the relationship between hepcidin and oral iron absorption in well children living in rural Gambia?
Aim 3:
Hypothesis: Anaemic children with low-grade inflammation have anaemia of inflammation with concomitant iron deficiency that results in inappropriately low levels of EPO production and reticulocytosis for their erythroid mass (Hb levels) levels.
Research Question: Is there decreased EPO synthesis and/or increased EPO resistance in anaemic children with low-grade inflammation living in rural Gambia?
Aim 4:
Hypothesis: First 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). 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 in anaemic and non-anaemic children with and without low-grade inflammation living in rural Gambia? Primary: To examine in detail the pathways by which low-grade inflammation causes iron deficiency anaemia in African children.
Secondary: To assess if anaemia of inflammation and resistance to erythropoietin play a role in causing and perpetuating anaemia in children living in rural Africa.
This is an observational study of 120 children who will be recruited at the routine vaccination clinics or pre-scheduled well-child check-ups at the Keneba clinic. Each child will be seen three times (at 6, 12 and 18 months) and the same protocol will be used at each visit.
Figure 1: Study design At each visit, children will be examined by the Research Clinician or PI using pre-determined validated checklists for possible sources of low-grade inflammation. Each participant will be given a clinical score for skin conditions, oral health, and respiratory infections/airway disease.
After the clinical examination, an oral iron absorption protocol will be initiated:
Step 1: A venous blood sample will be collected and assayed for full blood count (including reticulocyte count) and serum iron markers, hepcidin, erythropoietin (EPO), erythroferrone, IL-6 and EndoCab; Step 2: Children will be given an oral dose of liquid ferrous fumarate at 2mg/kg; Step 3: Between 3-4 hours later a venous blood sample will be drawn for measurement serum iron markers. The change in serum iron levels (measured before and after dosing) will be used as a direct measurement of iron absorption.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 120 is below the median of 270 across 368 observational studies indexed under Anemia.
Browse Anemia studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is young children to who's mothers/guardians the study protocol will be explained orally in the presence of a witness in case they are illiterate or in writing and we will not start any study specific procedure before informed consent is obtained
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.
Serum hepcidin level
To examine in detail the pathways by which low-grade inflammation causes iron deficiency anaemia in African children
Time frame: 18 months
clinical score of site and severity of infection and inflammation
Clinical score of skin infections, oral health, eye infections, upper and lower respiratory tract infections. see score below: Clinical score of inflammation and infection Total out of 81 Range 0-81 0= no inflammation/ infection 81= severe multi focal inflammation/infection
Time frame: 18 months
iron absorption
Markers of oral iron absorption - Serum iron concentration
Time frame: 18 months
Iron biomarkers - serum ferritin concentration
Time frame: 18 months
haematology parameters
Haematology parameters - haemoglobin concentration
Time frame: 18 months
inflammatory markers
Inflammatory markers in serum (C-reactive protein, AGP)
Time frame: 18 months
Stool parameters - parasites concentration
Time frame: 18 months
total iron binding capacity
Time frame: 18 months
serum transferrin concentration
Time frame: 18 months
soluble transferrin receptor (sTfR)
Time frame: 18 months
erythropoietin concentration
Time frame: 18 months
erythroferrone concentration
Time frame: 18 months
haematology parameters
red blood cell indices measured from full blood count
Time frame: 18 months
concentration of helminths in stool
Time frame: 18 months
calprotectin
measure of inflammation
Time frame: 18 months
Reg1b
measure of inflammation
Time frame: 18 months
lipocalin 2
measure of inflammation
Time frame: 18 months
Started May 2019 (actual). Primary completion is estimated for Dec 2020, 19 months after the start.
Of 124 non-industry observational studies under Anemia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 19 months is below that.
Counting every sponsor, half of 145 studies reached it within 30 months; a quarter within 12 and three quarters within 76.
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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