Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-01 @ 7:28 PM
Study NCT ID:
NCT05278793
Status:
UNKNOWN
Last Update Posted:
2022-03-14
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'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': 'C031621', 'term': 'ferrous fumarate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemoglobin level', 'timeFrame': '6 weeks after start treatment', 'description': 'The main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable.'}], 'secondaryOutcomes': [{'measure': 'Side effects', 'timeFrame': '6 weeks after start treatment', 'description': 'The following treatment related adverse effects will be analysed: headache, dizziness, nausea, vomiting, constipation, diarrhoea. These known side effects of ferrous fumarate will be analysed with a written questionnaire.'}, {'measure': 'Therapy compliance', 'timeFrame': '6 weeks after start treatment', 'description': "Therapy compliance will be analysed with a validated questionnaire (SMAQ).The SMAQ was considered 'positive' when a non-adherent patient was detected, that is, when there was a positive response to any of the qualitative questions (question 1-3), more than two doses missed over the past week, or over 2 days of total non-medication during the past 3 months."}, {'measure': 'Haemoglobin level at time of delivery', 'timeFrame': 'At time of delivery', 'description': 'When a subject is in labour a haemoglobin level will be measured.'}, {'measure': 'Term of delivery', 'timeFrame': 'At delivery', 'description': 'Gestational age at delivery.'}, {'measure': 'Birth weight', 'timeFrame': 'At delivery', 'description': 'The weight of the neonate.'}, {'measure': 'Parenteral iron ante- or postpartum', 'timeFrame': 'From start treatment until 1 week after delivery', 'description': 'The need for parental iron supplementation when oral supplementation is not sufficient.'}, {'measure': 'Blood transfusion postpartum', 'timeFrame': 'Until 1 week after delivery', 'description': 'The need for a blood transfusion postpartum because of anaemia as binary data (yes / no).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency.', 'detailedDescription': 'Background of the study:\n\nIron deficiency anaemia in pregnancy is common and the standard treatment is iron supplementation once or twice daily. But there is no evidence for the optimal dose of iron supplementation in pregnancy. In non-pregnant women intermittent oral iron supplementation on alternate days is proven to have a similar effect on haemoglobin levels as iron supplementation daily with less side effects. In pregnancy the need and absorption of iron is physiologically higher. Therefore the optimal dose may differ from non-pregnant women.\n\nThe adverse effects of iron supplementation, which are mainly gastrointestinal effects, seem to be related to the dose of iron supplementation. These effects often already exist physiologically in pregnancy and may increase with the use of iron supplementation. Therefore, a lower dose would be preferable in pregnancy if the effectiveness is similar.\n\nIn this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency. Our hypothesis is that intermittent oral iron supplementation is at least as effective as iron supplementation once daily and will give less adverse effects.\n\nObjective of the study:\n\nTo compare the efficacy, side effects and therapy compliance of intermittent (three times a week) versus daily oral iron supplementation for anaemia in pregnancy attributed to iron deficiency.\n\nStudy design:\n\nSingle-centre, non-inferiority, open-label randomised controlled trial.\n\nStudy population:\n\nPregnant women of 18 years and older with iron deficiency anaemia.\n\nIntervention:\n\nOne group will receive ferrous fumarate 200mg intermittent three times a week (for example on Monday, Wednesday and Friday) and one group will receive ferrous fumarate 200mg once daily.\n\nScreening for anaemia during the pregnancy will be done according the local protocol in the first trimester and at a gestational age of 30 weeks. In women at risk for anaemia extra haemoglobin level will be measured at a gestational age of 20 weeks.\n\nWhen a patient is eligible for the study she will be computer-randomised. Haemoglobin levels will be measured every 6 weeks after the start of the supplementation until the delivery. Side effects and therapy compliance will be evaluated with an interview.\n\nPrimary study parameters/outcome of the study:\n\nThe main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable. A multivariate analysis will be performed with gestational age/trimester at start iron supplementation, the duration of the treatment, use of other supplements, vegetarian diet and the use of proton pump inhibitors or H2 receptor antagonists.\n\nSecondary study parameters/outcome of the study:\n\nThe secondary endpoints are haemoglobin level at time of delivery, side effects, therapy compliance, term of delivery, birth weight, parenteral iron ante- or postpartum and blood transfusion postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women of 18 years and older\n* Iron deficiency anaemia (defined as: Anaemia (haemoglobin lower than cut-off value) AND mean corpuscular volume (MCV) 70-85 fl OR ferritin \\<30ug/L) OR mean corpuscular volume (MCV) \\< 70fl / hemoglobinopathy is ruled out.\n* Adequate mental health\n* Good command of the Dutch language\n* No participation in other research with medication\n* Informed consent\n\nExclusion Criteria:\n\n* Start of iron supplementation at pregnancy duration \\> 37 weeks (because of the limited time to achieve an increase in haemoglobin).\n* History of bariatric surgery, inflammatory bowel disease, coeliac disease or Helicobacter pylori infection (because of malabsorption of iron).\n* Patients who received blood transfusion or parental iron supplementation during the 3 months prior to screening (because of the effect on the haemoglobin level).\n* Patients with significant bleeding, blood donation or surgery during pregnancy (because of the effect on the haemoglobin level).\n* Allergy for iron.\n* Anaemia of other cause, such as a hemoglobinopathy.'}, 'identificationModule': {'nctId': 'NCT05278793', 'acronym': 'FER-IDIP', 'briefTitle': 'The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.', 'organization': {'class': 'OTHER', 'fullName': 'Martini Hospital Groningen'}, 'officialTitle': 'The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.', 'orgStudyIdInfo': {'id': 'NL77578.000.21'}, 'secondaryIdInfos': [{'id': '2021-005393-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent', 'description': 'This group will receive ferrous fumarate 200mg intermittent three times a week on alternate days.', 'interventionNames': ['Drug: Ferrous fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daily', 'description': 'This group will receive ferrous fumarate 200mg once daily.', 'interventionNames': ['Drug: Ferrous fumarate']}], 'interventions': [{'name': 'Ferrous fumarate', 'type': 'DRUG', 'description': 'Ferrous fumarate 200mg oral', 'armGroupLabels': ['Daily', 'Intermittent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728 NT', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Maryse M de Graaf, drs', 'role': 'CONTACT', 'email': 'marysedegraaf@gmail.com', 'phone': '+31505246868'}, {'name': 'Janna JM Munster, dr', 'role': 'CONTACT', 'email': 'j.munster@mzh.nl', 'phone': '+31505245132'}], 'facility': 'Martini Hospital Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Maryse M de Graaf, drs', 'role': 'CONTACT', 'email': 'marysedegraaf@gmail.come', 'phone': '+31505246868'}, {'name': 'Janna JM Munster, dr', 'role': 'CONTACT', 'email': 'j.munster@mzh.nl', 'phone': '+3155245132'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martini Hospital Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'dr. J.M. Munster, gynaecologist, principal investigator', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'drs', 'investigatorFullName': 'Maryse de Graaf', 'investigatorAffiliation': 'Martini Hospital Groningen'}}}}