Inflammation, Iron Deficiency and Anaemia Study 1

NCT04097639 | Unknown

• 1 other identifier: SCC 1664
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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 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:

1. 1.Use detailed clinical screening for possible origins of the low grade inflammation.
2. 2.Assess iron absorption and its relationship to iron and anaemia status, inflammation, EPO, erythroferrone and hepcidin.

Conditions

Anemia

Keywords

low-grade inflammation; anemia; erythroferrone

Outcome Measures

Primary Outcomes (2)

• Serum hepcidin level

  To examine in detail the pathways by which low-grade inflammation causes iron deficiency anaemia in African children

  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

  18 months

Secondary Outcomes (15)

• iron absorption

  18 months

• Iron biomarkers - serum ferritin concentration

  18 months

• haematology parameters

  18 months

• inflammatory markers

  18 months

• Stool parameters - parasites concentration

  18 months

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• )Male or female children ages 6-8 months at the time of study enrolment.
• )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:

• \) Acute illness
• \) 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).
• )Vaccination less than 7 days prior to study enrollment.
• )Administration of systemic antibiotic treatment within 3 days prior to study enrolment.
• )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).
• )Any history of maternal 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 Field Station

Keneba, The Gambia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Carla Cerami, MD

  Medical Research Council Unit at LSHTM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Cerami, MD

CONTACT

+2207875756; ccerami@mrc.gm

Elizabeth Ledger, MD

CONTACT

+2202980631.; 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: May 3, 2019
• First Posted: September 20, 2019
• Study Start: May 7, 2019
• Primary Completion: December 1, 2020
• Study Completion: November 1, 2021
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

TH (1)