Nutritional, Metabolic, Endocrine Paediatrics
Conditions
Interventions
Fe as FeSO4 powder
Fe as haem iron polypeptide dietary supplement
Sponsors
Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children (male or female) at 6 to 12 months of age. • Anaemic children with Hb 7.0 g/dl. • Parent/guardian with participant reside in study area and are able and willing to adhere to all protocol visits and procedures (willingness to stay in the study area for the 12 weeks of supplementation). • Healthy with no current illness and no chronic health problems as assessed by nursing team. • Signed or fingerprinted informed consent obtained from participants parent/guardian.
Exclusion criteria
Exclusion criteria: Children with history of low birthweight babies (ie less than 2.5kg at birth) or prematurity (ie born less than 37 weeks) will NOT be excluded unless extreme (<1500g or <34 weeks) • Formula fed infants or those whose mothers are planning to use commercially available infant formula as formula contains supplemental iron. • WHZ< -4 SD. • Recent hospitalization. • Not possible to collect venous blood samples at baseline. • Acute illness (once acute illness is resolved, if appropriate, as per nurse assessment, participant may be re-revaluated for eligibility). • Fever (for eligibility purpose defined as a body temperature greater than 37.5°C or mother report of fever) within 3 days prior to study initiation (once fever/acute illness is resolved, if appropriate, as per investigator assessment, participant may be re-revaluated for eligibility). • Administration of any investigational drug within 30 days prior to study initiation or planned administration during the study period. • Unwilling to avoid (to have their child avoid) the ingestion of other vitamin supplements or herbal/other traditional medications during the study period. • Any parentally reported history of chronic clinically significant disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease). • Any parentally reported history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections. • Any parentally reported history of sickle cell disease (HbSS), sickle cell anaemia, meningitis, seizures, Guillain-Barre´ syndrome, or other neurological disorders. • Any condition that in the opinion of the investigator or nursing team might compromise the safety or well-being of the participant or compromise adherence to protocol procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haemoglobin and serum ferritin after 84 days of iron supplementation. Haemoglobin and serum ferritin will be measured in venous blood collected at trial enrolment and 12 weeks after initiation of iron supplementation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Related to the primary objective: 1. Prevalence of children with anaemia (Hb <11g/dL) at study Day 84. 2. Prevalence of children with iron deficiency (ID) assessed as ferritin <12ug/L (or adjusted for the presence of inflammation) at Day 84. 3. Prevalence of children with iron deficiency anaemia (IDA) defined as Hb <11g/dL & sTfR/log Ferritin ratio <2.0 and ferritin <12ug/L (or <30 ug/L in the presence of inflammation) at Day 84. 4. Measures of iron status at Day 84 (serum iron, transferrin, transferrin saturation, sTfR, UIBC, MCV and reticulocyte haemoglobin) 5. Reticulocyte numbers at Day 84. 6. Hepcidin levels at Day 84. 7. Erythropoietin levels at Day 84. 8. Erythroferrone levels at Day 84. Related to secondary objective 1: 1. Incidence of maternal-reported illnesses over the entire intervention period. 2. Incidence of adverse events (AEs) over the entire intervention period. 3. Incidence of serious adverse events (SAEs) over the entire intervention period. 4. Inflammatory markers (CRP/AGP) level at Day 84. Related to secondary objective 2: 1. Markers of gut inflammation including, but not limited to, calprotectin. | — |
Countries
Gambia
Contacts
Public ContactMamadou Bah
PhD Candidate
Outcome results
None listed