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

NCT04095884 | Unknown DMC

• 1 other identifier: SCC 17097
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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. 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. 2.Assess iron absorption and its relationship to iron and anaemia status, inflammation, EPO, erythroferrone and hepcidin.

Conditions

Iron Deficiency, Anaemia in Children

Outcome Measures

Primary Outcomes (2)

• Change in Serum hepcidin from baseline to day 14

  Day 14

• Change in Clinical score of site and severity of infection and inflammation from baseline to day 14

  Day 14

Secondary Outcomes (3)

• serum iron levels

  Day 0, 3, 7 & 14

• Erythropoietin

  Day 0, 3, 7 & 14

• Erythroferrone

  Day 0, 3, 7 & 14

Study Arms (4)

Urinary Tract Infection

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

Upper respiratory tract infection

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

Lower respiratory tract infection

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

Diarrhoea/ gastroenteritis

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

Interventions

blood sampling PROCEDURE

observational study and no intervention will be given. only blood samples collected and treated with iron supplements

Diarrhoea/ gastroenteritis; Lower respiratory tract infection; Upper respiratory tract infection; Urinary Tract Infection

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

sick children with fever

You may qualify if:

• 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.

You may not qualify if:

• 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 systemic antibiotic treatment within 3 days prior to study enrolment.
• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University of Oxford: collaborator

Study Sites (1)

Keneba MRC Unit

West Kiang, City of Banjul, 0000, The Gambia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

samples will collected at baseline, day3 , day 7 and day 14

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Carla Cerami, MD

CONTACT

00220-4495442-6; ccerami@mrc.gm

Elizabeth Ledger, BMBCh

CONTACT

+220-4495442-6; eledger@mrc.gm

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 19, 2019
• Study Start: July 17, 2019
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

TH (1)