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.: PACTR202102892966266 Date of Approval: 03/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Iron Babies Pilot Supplementation Trial
Official scientific title Enhancing brain development by early iron supplementation of African infants: An enabling pilot study
Brief summary describing the background and objectives of the trial Healthy full-term babies are born with an endowment of iron accumulated in the fetal liver and stored as ferritin.The human breast milk contains very low levels of iron so the hepatic store of iron accrued in the uterus is used as a buffer to meet the needs of new tissue formation. Most of the body's iron is contained within haemoglobin and erythropoiesis is prioritized over organs including the brain if iron supply is restricted thus, iron deficiency occurs well ahead of anemia. The risk is greatest in infancy when iron needed for growth competes with erythropoiesis. Studies in infant humans, monkeys, lambs, and rats demonstrate that brain iron is reduced prior to anemia. A large body of evidence from both humans and animal models indicates the iron deficiency in early life can permanently alters the nervous and brain development. Pre-clinical models have clearly shown that these effects are due to brain tissue iron deficiency and not anemia. Therefore, treatment of iron deficiency after the onset of anemia may not have any effect on the neurological deficits. The goal of this study is to conduct a pilot randomised trial aimed at improving neurological development by introducing iron supplements much earlier in infancy than has previously been attempted in a low-income setting. The primary objective is: Will provision of a daily iron supplement as pediatric drop for 98 days starting at 6 weeks of age reverse the decline of serum iron. The secondary objectives includes: - Can we introduce supplementary iron - Would iron supplementation at this age cause diarrhoea? - Would iron supplementation cause an increase in fecal iron losses?
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Iron Babies
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 01/02/2021
Actual trial start date
Anticipated date of last follow up 01/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
LEO 19092 London School of Hygiene and Tropical Medicine
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 Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ferrous sulphate 1.5mg/kg daily 98 days Daily drops of 1.5mg/kg iron as ferrous sulphate will be given to this arm of the study for 98 days 50
Control Group Placebo 1.5mg per kilogram will be given daily 98 days 1.5mg per kilogram of the placebo will be given to this group on a daily base for 98 days. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Infants (male or female) at 6 weeks of age • Breast fed infants (with plans to continue breastfeeding through 6 months of age). • Parent/guardian with participant reside in study site area and are able and willing to adhere to all protocol visits and procedures (willingness to stay in the study area for the 14 weeks of supplementation). • Healthy with no current illness and no chronic health problems. • Signed or fingerprinted informed consent obtained from participants parent/guardian. • Low birthweight babies (i.e. less than 2.5kg at birth) or babies born prematurely (i.e. less than 37 weeks) will NOT be excluded. • Formula fed infants or those planning to terminate exclusive breast feeding before 6months of age. • Acute illness (once acute illness is resolved, if appropriate, as per investigator 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 (their child to avoid) the ingestion of supplements or herbal/other traditional medications during the study period. • Any history of or evidence for chronic clinically significant (as per investigator assessment) disorder or disease (including, but not limited to, immunodeficiency, autoimmunity, congenital abnormality, bleeding disorder, and pulmonary, cardiovascular, metabolic, neurologic, renal, or hepatic disease). • Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections. • History of meningitis, seizures, Guillain-Barré syndrome, or other neurological disorders. • Any condition that in the opinion of the investigator might compromise the safety or well- being of the participant or compromise adherence to protocol procedures. Infant: 0 Month-23 Month 6 Week(s) 6 Week(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 27/07/2020 Gambia Government and MRC Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Atlantic Road, Fajara Banjul 273 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum iron after 98 days of iron supplementation. Serum iron will be measured in venous blood collected at trial enrolment and 14 weeks after initiation of iron supplementation. At trial enrolment and 14 weeks after initiation of iron supplementation.
Secondary Outcome The proportion of babies with anaemia (Hb <11 g/dL) and proportion of iron deficiency (sTfR/logFerritin ratio <2.0 hepcidin < 5.5 ng/L) at day 98. At day 98.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Council The Gambia at London School of Hygiene ans Tropical Medicine Kenaba Field Station Keneba Banjul Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Joint Global Health Trials North Star Avenue Swindon United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council at London School of Hygiene and Tropical Medicine Atlantic Road, Fajara Banjul Gambia Research Institute
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene and Tropical Medicine Keppel Street, London WC1E 7HT London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Carla Cerami ccerami@mrc.gm +2207875756 Atlantic Boulevard, Fajara
City Postal code Country Position/Affiliation
Banjul Gambia Medical Research Council at London School of Hygiene and Tropical Medicine
Role Name Email Phone Street address
Scientific Enquiries Carla Cerami ccerami@mrc.gm +2207875756 Atlantic Boulevard, Fajara
City Postal code Country Position/Affiliation
Banjul Gambia Medical Research Council at London School of Hygiene and Tropical Medicine
Role Name Email Phone Street address
Public Enquiries Elizabeth Stanley Batchilly esbatchilly@mrc.gm +2207036383 Atlantic Boulevard, Fajara
City Postal code Country Position/Affiliation
Banjul Gambia Medical Research Council at London School of Hygiene and Tropical Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data about the participants may be shared via a public data repository or by sharing directly with other researchers, participant information will not be identifiable from this information. Study Protocol 12 months The study data will be stored in a limited access, password protected database so that only staff who have the required permissions can view the study records.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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