Iron-deficiencyPhase 3Iron BabiesNCT04751994
Iron Babies Pilot Supplementation Trial
A Phase 3 study testing Iron drops/Ferrous sulphate in people with Iron-deficiency and Anaemia in Early Infancy, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
2-arm, double blind, placebo controlled, randomised trial, with 50 6-week-old infants per arm randomized to 98 days of daily iron (1.5mg/kg/day as ferrous sulphate) or placebo drops Read more about this study
- Who is it for?
- Ages 6 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Anaemia in Early Infancy
- What is being tested?
- Iron drops/Ferrous sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThe Gambia
- Study dates
- 3 Aug 2021to 9 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants (male or female) from 6 weeks to 10 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
Who cannot join
- Low birthweight babies (ie less than 2.5kg at birth) or babies born prematurely (ie 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Brain Development by Early Iron Supplementation of African Infants: An Enabling Pilot Study
2-arm, double blind, placebo controlled, randomised trial, with 50 6-week-old infants per arm randomized to 98 days of daily iron (1.5mg/kg/day as ferrous sulphate) or placebo drops
Read the detailed description
Healthy infants will be randomised to receive daily supplementation from 6-20wks of either a) iron drops or b) placebo drops. Infants with significant illness or any clinical syndromes that would affect interpretation will be excluded. Low birthweight infants and infants born prematurely will not be excluded. Venous blood samples will be collected at enrollment (age 6 weeks) and after 14 weeks (98 days) of iron/placebo supplementation.
Participants will be visited daily in their villages by Fieldworkers (FW) to administer the iron/placebo dose and will interview mothers to complete a short health questionnaire. The iron will be dosed at 75% of WHO guideline dose (ie 1.5mg/kg/day). Weekly, a more detailed morbidity and breastfeeding questionnaires will be administered. Infants will be weighed and measured monthly, along with a faecal sample being taken.
During the daily visits, the FWs will record any adverse events (AEs) and ensure the safety of participants. If a child is found unwell or if the mother/guardian reports that the child is unwell, the study nurse will check on the child and decide on treatment/referral to the nearest health centre
- Conditions
- Iron-deficiency, Anaemia in Early Infancy
- Being tested
- Iron drops/Ferrous sulphate, Placebo drops
- Keywords
- anaemia, infant
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron drops/Ferrous sulphateDietary supplement
Also called Ferrous Sulphate syrup
participant will consume daily drops of iron
Placebo dropsDietary supplement
Also called Sorbitol Solution 70%
Participants will consume daily drops of placebo
| Study group | Role | What they receive |
|---|---|---|
| Iron supplement/ ferrous sulphate syrup | Experimental | administration of daily iron drops, 7.5mg/day iron as ferrous sulphate Receives: Dietary Supplement: Iron drops/Ferrous sulphate |
| supplement with placebo | Placebo comparator | administration of daily placebo drops Receives: Dietary Supplement: Placebo drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum iron level
Serum iron concentration at days 0 and 99
Measured: at day 0 and at day 99
Secondary outcomes (13)
Haemoglobin concentration
Haemoglobin concentration at days 0 and 99
Measured: at day 0 and at day 99
Percentage of infants with anaemia
Percentage of infants with anaemia (defined as: Hb< 110g/L, )
Measured: at day 99
breast feeding
Duration of breast feeding assessed weekly, up to study day 98.
Measured: weekly up to week 14
maternal reported illnesses
Proportion of maternal-reported illnesses assessed daily up to study day 99.
Measured: daily up to day 99
adverse events assessment
Proportion of adverse events assessed daily, up to study day 99
Measured: daily up to day 99
Serious adverse events (SAE) assessment
Proportion of serious adverse events assessed daily, up to study day 99
Measured: daily up to day 99
raised inflammatory markers assessment
Proportion of raised inflammatory markers (CRP/AGP)
Measured: after 98 days of supplementation
iron deficiency anemia (Hb < 11 g/dL & sTfR/logFerritin ratio < 2.0 and ferritin < 12 ug/L or < 30 ug/L in the presence of inflammation
Proportion of children that are iron deficiency anaemia (Hb < 11 g/dL \& sTfR/logFerritin ratio < 2.0 and ferritin < 12 ug/L or < 30 ug/L in the presence of inflammation)
Measured: at day 0 and day 99
Fecal iron after supplementation
Fecal iron assessed at day 0 and day 99
Measured: day 0 and day 99
Iron regulation
Hepcidin levels at day 0 and day 99
Measured: day 0 and day 99
Reticulocytes at day 0 and day 99
Reticulocytes at day 0 and day 99
Measured: day 0 and day 99
Erythropoietin at days 0 and 99
Erythropoietin at days 0 and 99
Measured: day 0 and 99
Erythroferrone at days 0 and 99
Erythroferrone at days 0 and 99
Measured: day 0 and 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start3 Aug 2021
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Daily iron (7.5mg/day as ferrous sulphate) or placebo drops starting from six to ten weeks of age for 98 days. Please note that the daily iron supplement is the intervention product/drug
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla Cerami, MD, PhD, Principal investigator, Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751994
- Sponsor's protocol ID
- LEO 19092
- Acronym
- Iron Babies
- Status last verified
- May 2022
- First submitted
- 27 Jan 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept anonymous. There are currently no plans to share individual patient data beyond the investigator team. However, following all requisite approvals, an anonymized copy of the data can be made available for sharing. All key findings from this study will be submitted for publication in peer-reviewed journals.
Publications
Stelle I, Bah M, Silverio SA, Verhoef H, Comma E, Prentice AM, Moore SE, Cerami C. Iron supplementation of breastfed Gambian infants from 6 weeks to 6 months of age: protocol for a randomised controlled trial. Wellcome Open Res. 2022 Jan 18;7:16. doi: 10.12688/wellcomeopenres.17507.1. eCollection 2022.
PubMed 36874582
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Brain Development by Early Iron Supplementation of African Infants: An Enabling Pilot Study
- ClinicalTrials.gov ID
- NCT04751994
- Acronym / sponsor ID
- Iron Babies / LEO 19092
- Conditions
- Iron-deficiency, Anaemia in Early Infancy
- Keywords
- anaemia, infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
2-arm, double blind, placebo controlled, randomised trial, with 50 6-week-old infants per arm randomized to 98 days of daily iron (1.5mg/kg/day as ferrous sulphate) or placebo drops
Detailed description
Healthy infants will be randomised to receive daily supplementation from 6-20wks of either a) iron drops or b) placebo drops. Infants with significant illness or any clinical syndromes that would affect interpretation will be excluded. Low birthweight infants and infants born prematurely will not be excluded. Venous blood samples will be collected at enrollment (age 6 weeks) and after 14 weeks (98 days) of iron/placebo supplementation.
Participants will be visited daily in their villages by Fieldworkers (FW) to administer the iron/placebo dose and will interview mothers to complete a short health questionnaire. The iron will be dosed at 75% of WHO guideline dose (ie 1.5mg/kg/day). Weekly, a more detailed morbidity and breastfeeding questionnaires will be administered. Infants will be weighed and measured monthly, along with a faecal sample being taken.
During the daily visits, the FWs will record any adverse events (AEs) and ensure the safety of participants. If a child is found unwell or if the mother/guardian reports that the child is unwell, the study nurse will check on the child and decide on treatment/referral to the nearest health centre
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Daily iron (7.5mg/day as ferrous sulphate) or placebo drops starting from six to ten weeks of age for 98 days. Please note that the daily iron supplement is the intervention product/drug
| Arm | Type | Receives |
|---|---|---|
| Iron supplement/ ferrous sulphate syrup | Experimental | Dietary Supplement: Iron drops/Ferrous sulphateadministration of daily iron drops, 7.5mg/day iron as ferrous sulphate |
| supplement with placebo | Placebo comparator | Dietary Supplement: Placebo dropsadministration of daily placebo drops |
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants (male or female) from 6 weeks to 10 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
Key exclusion criteria (10 listed)
- Low birthweight babies (ie less than 2.5kg at birth) or babies born prematurely (ie 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron drops/Ferrous sulphateAlso: Ferrous Sulphate syrupparticipant will consume daily drops of iron | Dietary supplement | Iron supplement/ ferrous sulphate syrup |
| Placebo dropsAlso: Sorbitol Solution 70%Participants will consume daily drops of placebo | Dietary supplement | supplement with placebo |
Primary outcome
serum iron level
Time frame: at day 0 and at day 99
Serum iron concentration at days 0 and 99
13 secondary outcomes
Haemoglobin concentration
Time frame: at day 0 and at day 99
Percentage of infants with anaemia
Time frame: at day 99
breast feeding
Time frame: weekly up to week 14
maternal reported illnesses
Time frame: daily up to day 99
adverse events assessment
Time frame: daily up to day 99
Serious adverse events (SAE) assessment
Time frame: daily up to day 99
raised inflammatory markers assessment
Time frame: after 98 days of supplementation
iron deficiency anemia (Hb < 11 g/dL & sTfR/logFerritin ratio < 2.0 and ferritin < 12 ug/L or < 30 ug/L in the presence of inflammation
Time frame: at day 0 and day 99
Fecal iron after supplementation
Time frame: day 0 and day 99
Iron regulation
Time frame: day 0 and day 99
Reticulocytes at day 0 and day 99
Time frame: day 0 and day 99
Erythropoietin at days 0 and 99
Time frame: day 0 and 99
Erythroferrone at days 0 and 99
Time frame: day 0 and 99
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Derived from this study: PubMed 36874582Stelle I, Bah M, Silverio SA, Verhoef H, Comma E, Prentice AM, Moore SE, Cerami C. Iron supplementation of breastfed Gambian infants from 6 weeks to 6 months of age: protocol for a randomised controlled trial. Wellcome Open Res. 2022 Jan 18;7:16. doi: 10.12688/wellcomeopenres.17507.1. eCollection 2022.
- Individual participant dataSharing planned: No. Data will be kept anonymous. There are currently no plans to share individual patient data beyond the investigator team. However, following all requisite approvals, an anonymized copy of the data can be made available for sharing. All key findings from this study will be submitted for publication in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Cerami, MD, PhD principal investigator
Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron drops/Ferrous sulphate in people with Iron-deficiency and Anaemia in Early Infancy, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum iron level (time frame: at day 0 and at day 99). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.