Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT04751994
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2021-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Babies Pilot Supplementation Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020748', 'term': 'ferrous sulfate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This will be a two-arm, randomised, placebo-controlled double-blind study. Children will be randomised (1:1) to iron drops or placebo arm.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Daily iron (7.5mg/day as ferrous sulphate) or placebo drops starting from six to ten weeks of age for 98 days.\n\nPlease note that the daily iron supplement is the intervention product/drug'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum iron level', 'timeFrame': 'at day 0 and at day 99', 'description': 'Serum iron concentration at days 0 and 99'}], 'secondaryOutcomes': [{'measure': 'Haemoglobin concentration', 'timeFrame': 'at day 0 and at day 99', 'description': 'Haemoglobin concentration at days 0 and 99'}, {'measure': 'Percentage of infants with anaemia', 'timeFrame': 'at day 99', 'description': 'Percentage of infants with anaemia (defined as: Hb\\< 110g/L, )'}, {'measure': 'breast feeding', 'timeFrame': 'weekly up to week 14', 'description': 'Duration of breast feeding assessed weekly, up to study day 98.'}, {'measure': 'maternal reported illnesses', 'timeFrame': 'daily up to day 99', 'description': 'Proportion of maternal-reported illnesses assessed daily up to study day 99.'}, {'measure': 'adverse events assessment', 'timeFrame': 'daily up to day 99', 'description': 'Proportion of adverse events assessed daily, up to study day 99'}, {'measure': 'Serious adverse events (SAE) assessment', 'timeFrame': 'daily up to day 99', 'description': 'Proportion of serious adverse events assessed daily, up to study day 99'}, {'measure': 'raised inflammatory markers assessment', 'timeFrame': 'after 98 days of supplementation', 'description': 'Proportion of raised inflammatory markers (CRP/AGP)'}, {'measure': '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', 'timeFrame': 'at day 0 and day 99', 'description': '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)'}, {'measure': 'Fecal iron after supplementation', 'timeFrame': 'day 0 and day 99', 'description': 'Fecal iron assessed at day 0 and day 99'}, {'measure': 'Iron regulation', 'timeFrame': 'day 0 and day 99', 'description': 'Hepcidin levels at day 0 and day 99'}, {'measure': 'Reticulocytes at day 0 and day 99', 'timeFrame': 'day 0 and day 99', 'description': 'Reticulocytes at day 0 and day 99'}, {'measure': 'Erythropoietin at days 0 and 99', 'timeFrame': 'day 0 and 99', 'description': 'Erythropoietin at days 0 and 99'}, {'measure': 'Erythroferrone at days 0 and 99', 'timeFrame': 'day 0 and 99', 'description': 'Erythroferrone at days 0 and 99'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anaemia, infant'], 'conditions': ['Iron-deficiency', 'Anaemia in Early Infancy']}, 'referencesModule': {'references': [{'pmid': '36874582', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nParticipants 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.\n\nDuring 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants (male or female) from 6 weeks to 10 weeks of age.\n* Breast fed infants (with plans to continue breastfeeding through 6 months of age).\n* 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).\n* Healthy with no current illness and no chronic health problems.\n* Signed or fingerprinted informed consent obtained from participants parent/guardian\n\nExclusion Criteria:\n\n* Low birthweight babies (ie less than 2.5kg at birth) or babies born prematurely (ie less than 37 weeks) will NOT be excluded.\n* Formula fed infants or those planning to terminate exclusive breast feeding before 6months of age.\n* Acute illness (once acute illness is resolved, if appropriate, as per investigator assessment, participant may be re-revaluated for eligibility)\n* 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).\n* Administration of any investigational drug within 30 days prior to study initiation or planned administration during the study period.\n* Unwilling to avoid (their child to avoid) the ingestion of supplements or herbal/other traditional medications during the study period.\n* 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).\n* Any history of human immunodeficiency virus, chronic hepatitis B or chronic hepatitis C infections.\n* History of meningitis, seizures, Guillain-Barré syndrome, or other neurological disorders.\n* 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'}, 'identificationModule': {'nctId': 'NCT04751994', 'acronym': 'Iron Babies', 'briefTitle': 'Iron Babies Pilot Supplementation Trial', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'Enhancing Brain Development by Early Iron Supplementation of African Infants: An Enabling Pilot Study', 'orgStudyIdInfo': {'id': 'LEO 19092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron supplement/ ferrous sulphate syrup', 'description': 'administration of daily iron drops, 7.5mg/day iron as ferrous sulphate', 'interventionNames': ['Dietary Supplement: Iron drops/Ferrous sulphate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'supplement with placebo', 'description': 'administration of daily placebo drops', 'interventionNames': ['Dietary Supplement: Placebo drops']}], 'interventions': [{'name': 'Iron drops/Ferrous sulphate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ferrous Sulphate syrup'], 'description': 'participant will consume daily drops of iron', 'armGroupLabels': ['Iron supplement/ ferrous sulphate syrup']}, {'name': 'Placebo drops', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Sorbitol Solution 70%'], 'description': 'Participants will consume daily drops of placebo', 'armGroupLabels': ['supplement with placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Keneba', 'country': 'The Gambia', 'facility': 'Keneba Field Station', 'geoPoint': {'lat': 13.32889, 'lon': -16.015}}], 'overallOfficials': [{'name': 'Carla Cerami, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}