A Phase 3 interventional study of Iron drops/Ferrous sulphate and Placebo drops in Iron-deficiency and Anaemia in Early Infancy, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Gambia. Open to participants aged 6 Weeks to 10 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 3, Interventional, and Prevention
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
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
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
administration of daily iron drops, 7.5mg/day iron as ferrous sulphate
Dietary Supplement: Iron drops/Ferrous sulphate
administration of daily placebo drops
Dietary Supplement: Placebo drops
Drug pages: Iron · Ferrous sulfate
participant will consume daily drops of iron
Also known as: Ferrous Sulphate syrup
Participants will consume daily drops of placebo
Also known as: Sorbitol Solution 70%
serum iron level
Serum iron concentration at days 0 and 99
Time frame: at day 0 and at day 99
Haemoglobin concentration
Haemoglobin concentration at days 0 and 99
Time frame: at day 0 and at day 99
Percentage of infants with anaemia
Percentage of infants with anaemia (defined as: Hb\< 110g/L, )
Time frame: at day 99
breast feeding
Duration of breast feeding assessed weekly, up to study day 98.
Time frame: weekly up to week 14
maternal reported illnesses
Proportion of maternal-reported illnesses assessed daily up to study day 99.
Time frame: daily up to day 99
adverse events assessment
Proportion of adverse events assessed daily, up to study day 99
Time frame: daily up to day 99
Serious adverse events (SAE) assessment
Proportion of serious adverse events assessed daily, up to study day 99
Time frame: daily up to day 99
raised inflammatory markers assessment
Proportion of raised inflammatory markers (CRP/AGP)
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
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)
Time frame: at day 0 and day 99
Fecal iron after supplementation
Fecal iron assessed at day 0 and day 99
Time frame: day 0 and day 99
Iron regulation
Hepcidin levels at day 0 and day 99
Time frame: day 0 and day 99
Reticulocytes at 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
Erythropoietin at days 0 and 99
Time frame: day 0 and 99
Erythroferrone at days 0 and 99
Erythroferrone at days 0 and 99
Time frame: day 0 and 99
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Iron · Ferrous sulfate
London School of Hygiene and Tropical Medicine →