Efficacy and safety of hepcidin-based screen-and-treat approaches using two different doses versus a standard universal approach of iron supplementation in young children in rural Gambia: a double-blind randomised controlled trial

Autor: Sarah Mulwa, Amat Bah, Rita Wegmüller, Morgan M. Goheen, Diego Moretti, Lindsay Kendall, Andrew M. Prentice, Carla Cerami
Jazyk: angličtina
Rok vydání: 2016
Předmět:
0301 basic medicine
Male
Pediatrics
Prevalence
Hepcidin
Rural Health
Gut flora
law.invention
Hemoglobins
Study Protocol
0302 clinical medicine
Randomized controlled trial
Clinical Protocols
law
Mass Screening
030212 general & internal medicine
Micronutrients
Prospective Studies
Children
biology
Anemia
Iron-Deficiency
Sub-Saharan Africa
Iron deficiency
Micronutrient
Female
Gambia
Safety
medicine.medical_specialty
Anaemia
03 medical and health sciences
Double-Blind Method
Hepcidins
Iron deficiency anaemia
medicine
Humans
Ferrous Compounds
Pediatrics
Perinatology
and Child Health
Adverse effect
Developing Countries
Iron supplementation
business.industry
Infant
biology.organism_classification
medicine.disease
030104 developmental biology
Pediatrics
Perinatology and Child Health
Dietary Supplements
biology.protein
Rural Health Services
business
Malaria
Biomarkers
Follow-Up Studies
Zdroj: BMC Pediatrics, 16
BMC Pediatrics
ISSN: 1471-2431
Popis: Background Iron deficiency prevalence rates frequently exceed 50 % in young children in low-income countries. The World Health Organization (WHO) recommended universal supplementation of young children where anaemia rates are >40 %. However, large randomized trials have revealed that provision of iron to young children caused serious adverse effects because iron powerfully promotes microbial growth. Hepcidin – the master regulator of iron metabolism that integrates signals of infection and iron deficiency – offers the possibility of new solutions to diagnose and combat global iron deficiency. We aim to evaluate a hepcidin-screening-based iron supplementation intervention using hepcidin cut-offs designed to indicate that an individual requires iron, is safe to receive it and will absorb it. Methods The study is a proof-of-concept, three-arm, double blind, randomised controlled, prospective, parallel-group non-inferiority trial. Children will be randomised to receive, for a duration of 12 weeks, one of three multiple micronutrient powders (MNP) containing: A) 12 mg iron daily; B) 12 mg or 0 mg iron daily based on a weekly hepcidin screening indicating if iron can be given for the next seven days or not; C) 6 mg or 0 mg iron daily based on a weekly hepcidin screening indicating if iron can be given for the next seven days or not. The inclusion criteria are age 6-23 months, haemoglobin (Hb) concentration between 7 and 11 g/dL, z-scores for Height-for-Age, Weight-for-Age and Weight-for-Height > -3 SD and free of malaria. Hb concentration at 12 weeks will be used to test whether the screen-and-treat approaches are non-inferior to universal supplementation. Safety will be assessed using caregiver reports of infections, in vitro bacterial and P. falciparum growth assays and by determining the changes in the gut microbiota during the study period. Discussion A screen-and-treat approach using hepcidin has the potential to make iron administration safer in areas with widespread infections. If this proof-of-concept study shows promising results the development of a point-of-care diagnostic test will be the next step.
BMC Pediatrics, 16
ISSN:1471-2431
Databáze: OpenAIRE
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