Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210523178727 Date of Approval: 12/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Haem iron supplementation to combat iron deficiency and anaemia in African children - IDeA Study 3
Official scientific title Haem iron supplementation to combat iron deficiency and anaemia in African children
Brief summary describing the background and objectives of the trial Parallel-arm, double blinded, individually randomised controlled trial, with 104 infants per arm. Anaemic but otherwise healthy children 6-12 months of age will be randomised to receive daily supplementation for 84 days of either a) ferrous sulphate or b) haem iron. Infants with significant illness or any clinical syndromes that would affect interpretation will be excluded. Children who were born with low birthweight (LBW) and infants born prematurely will not be excluded unless extreme (estimated <1500g or <34wks). Venous blood samples will be collected at enrolment (age 6- 12 months of age) and after 12 weeks (84 days) of ferrous sulphate/ haem iron supplementation. Participants will be visited daily in their homes by fieldworkers (FWs) to administer the ferrous sulphate/haem iron supplementation dose and will interview parents/guardians to complete a short health questionnaire. The iron will be dosed as per the WHO guideline dose for a 6-12 months old infant (ie 10 mg/day of elemental iron) (World Health Organization. 2016. Guideline Daily Iron Supplementation in Infants and Children. World Health Organization.) Weekly breastfeeding questionnaires will be administered. At baseline and endline, 3.5ml of whole blood and a fecal sample will be collected. Anthropometric measurements will also be taken. During the daily visits, the FWs will record any maternal reported adverse events (AEs) on the daily health questionnaire to ensure the safety of participants. If an infant is found unwell or if the mother/guardian reports that the infant is unwell, the study nurse will check on the infant and decide on treatment/referral to the trial clinician and nearest health centre.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IDeA Study 3
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2022
Actual trial start date
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 208
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Fe as FeSO4 powder daily 10 mg/day 12 weeks The products will be given as a daily dose. The supplements will be given to the participants by the field workers using individual spoons. Each daily dose will be contained in a capsule. On the day of administration, the field assistant will open the respective capsule (treatment code according to the randomisation) and place it on a spoon with 2 mls of water. The dose will be administered directly into the child’s mouth using the spoon. 104 Active-Treatment of Control Group
Experimental Group Fe as haem iron polypeptide dietary supplement 1 dose/day containing 10 mg 12 weeks The products will be given as a daily dose. The supplements will be given to the participants by the field workers using individual spoons. Each daily dose will be contained in a capsule. On the day of administration, the field assistant will open the respective capsule (treatment code according to the randomisation) and place it on a spoon with 2 mls of water. The dose will be administered directly into the child’s mouth using the spoon. 104
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children (male or female) at 6 to 12 months of age. • Anaemic children with Hb <11.0 g/dl and >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. 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-Barré 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. Infant: 13 Month(s)-24 Month(s) 6 Month(s) 12 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/09/2022 The Gambia Government MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Fajara Banjul 273 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. 84 days
Secondary Outcome 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. 84 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Council Unit The Gambia at London School of Hygiene and Medicine Keneba Banjul 273 Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council Infection and hepcidin mediated iron deficiency anaemia in African children Medical Research Council 2nd Floor David Phillips Building Polaris House North Star Avenue Swindon London SN2 1FL United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine Atlantic Boulevard, Fajara Banjul 273 Gambia Research institution
COLLABORATORS
Name Street address City Postal code Country
Hans Verhoef Division of Human Nutrition and Health, Wageningen University Wageningen 6700 Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Carla Cerami Cerami ccerami@mrc.gm 02207875756 Atlantic Boulevard Road Fajara
City Postal code Country Position/Affiliation
Banjul 273 Gambia Principal investigator
Role Name Email Phone Street address
Scientific Enquiries Andrew M Prentice aprentice@mrc.gm 00447867628617 Atlantic Boulevard Road, Fajara
City Postal code Country Position/Affiliation
Banjul 273 Gambia Nutrition and Planetary Health Theme Leader
Role Name Email Phone Street address
Public Enquiries Mamadou Bah Mamadou.Bah@lshtm.ac.uk 02207614091 Atlantic Boulevard Road, Fajara
City Postal code Country Position/Affiliation
Banjul 273 Gambia PhD Candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymized trial data will be made publicly available to the scientific community through a data repository. An appropriate data repository will be selected by the sponsor after discussion with research data experts and in accordance with trial agreements and data sharing regulations Study Protocol Main trial report after data analysis will be communicated
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www. mrc.gm No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information