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Inflammation, Iron Deficiency and Anaemia Study 1

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ClinicalTrials.gov Identifier: NCT04097639
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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

Condition or disease
Anemia

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Designed to Elucidate the Pathways by Which Low-grade Inflammation Contributes to Anaemia in Rural African Children From 6 Months to 2 Years of Age
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron




Primary Outcome Measures :
  1. Serum hepcidin level [ Time Frame: 18 months ]
    To examine in detail the pathways by which low-grade inflammation causes iron deficiency anaemia in African children

  2. clinical score of site and severity of infection and inflammation [ Time Frame: 18 months ]

    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



Secondary Outcome Measures :
  1. iron absorption [ Time Frame: 18 months ]
    Markers of oral iron absorption - Serum iron concentration

  2. Iron biomarkers - serum ferritin concentration [ Time Frame: 18 months ]
  3. haematology parameters [ Time Frame: 18 months ]
    Haematology parameters - haemoglobin concentration

  4. inflammatory markers [ Time Frame: 18 months ]
    Inflammatory markers in serum (C-reactive protein, AGP)

  5. Stool parameters - parasites concentration [ Time Frame: 18 months ]
  6. total iron binding capacity [ Time Frame: 18 months ]
  7. serum transferrin concentration [ Time Frame: 18 months ]
  8. soluble transferrin receptor (sTfR) [ Time Frame: 18 months ]
  9. erythropoietin concentration [ Time Frame: 18 months ]
  10. erythroferrone concentration [ Time Frame: 18 months ]
  11. haematology parameters [ Time Frame: 18 months ]
    red blood cell indices measured from full blood count

  12. concentration of helminths in stool [ Time Frame: 18 months ]
  13. calprotectin [ Time Frame: 18 months ]
    measure of inflammation

  14. Reg1b [ Time Frame: 18 months ]
    measure of inflammation

  15. lipocalin 2 [ Time Frame: 18 months ]
    measure of inflammation


Biospecimen Retention:   Samples With DNA
Plasma and serum


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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • 1)Male or female children ages 6-8 months at the time of study enrolment.
  • 2)Signed or fingerprinted or personally marked written informed consent obtained from their parent/guardian.
  • 3)Parent/guardian plans for subject to reside in study site area and are able and willing to adhere to all protocol visits and procedures.

Exclusion Criteria:

  • 1) Acute illness
  • 2) 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).
  • 3)Vaccination less than 7 days prior to study enrollment.
  • 4)Administration of immunosuppressants or other immune-modifying agents within 90 days prior to study IP administration (e.g., systemic corticosteroids at doses equivalent to ≥ 0.5 mg/kg/day of prednisone for more than 14 days; topical steroids including inhaled and intranasal steroids are not exclusionary).
  • 5)Administration of systemic antibiotic treatment within 3 days prior to study enrolment.
  • 6)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).
  • 7)Any history of maternal human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.
  • 8)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.
  • 9)Participation in another MRC study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097639


Contacts
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Contact: Carla Cerami, MD +2207875756 ccerami@mrc.gm
Contact: Elizabeth Ledger, MD +2202980631. eledger@mrc.gm

Locations
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Gambia
Keneba Field Station Recruiting
Keneba, Gambia
Contact: Carla Cerami, MD    +2207875756    ccerami@mrc.gm   
Contact: Elizabeth Ledger, MD    +2202980631    eledger@mrc.gm   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Oxford
Investigators
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Principal Investigator: Carla Cerami, MD Medical Research Council Unit at LSHTM

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT04097639     History of Changes
Other Study ID Numbers: SCC 1664
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London School of Hygiene and Tropical Medicine:
low-grade inflammation
anemia
erythroferrone
Additional relevant MeSH terms:
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Anemia
Inflammation
Pathologic Processes
Hematologic Diseases