Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 3:58 AM
Study NCT ID:
NCT07210450
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2025-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013789', 'term': 'Thalassemia'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pulmonary Artery Pressure (PAP)', 'timeFrame': 'Baseline to 60 days', 'description': 'Pulmonary artery pressure (PAP) will be measured by Doppler echocardiography at baseline and at 60 days. The primary endpoint is the change in PAP (ΔPAP = Follow-up PAP - Baseline PAP) to assess whether L-glutamine reduces pulmonary artery pressure compared with standard care alone.'}], 'secondaryOutcomes': [{'measure': 'Clinical Response Rate', 'timeFrame': '60 days', 'description': 'Proportion of participants achieving either an absolute reduction in PAP ≥10 mmHg or a relative reduction ≥20% from baseline.'}, {'measure': 'Safety and Tolerability of L-Glutamine', 'timeFrame': 'Baseline to 60 days', 'description': 'Monitoring of adherence, adverse events, and treatment discontinuations related to L-glutamine supplementation.'}, {'measure': 'Iron Load', 'timeFrame': 'Baseline to 60 days', 'description': 'Association between change in pulmonary artery pressure (ΔPAP) and iron overload indices (Cardiac T2\\*, Liver T2\\*, and Liver Iron Concentration).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['L-glutamine', 'Non-transfusion Dependent Thalassemia', 'pulmonary artery pressure'], 'conditions': ['Pulmonary Artery Pressure', 'Thalassemia', 'Non-transfusion Dependent Thalassemia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn whether L-glutamine can help lower pulmonary artery pressure in adults with non-transfusion-dependent thalassemia (NTDT).\n\nThe main questions it aims to answer are:\n\nDoes L-glutamine reduce pulmonary artery pressure after 60 days of treatment?\n\nIs the effect of L-glutamine different from standard care alone?\n\nResearchers will compare two groups:\n\nIntervention group: Participants receive oral L-glutamine in addition to their standard treatment.\n\nControl group: Participants continue with standard treatment only.\n\nParticipants will:\n\nTake either L-glutamine (by mouth) or standard care for 60 days. Undergo echocardiography at the beginning and end of the study to measure pulmonary artery pressure.\n\nAttend follow-up visits to monitor safety, adherence, and possible side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years), any sex.\n* Diagnosis of non-transfusion-dependent β-thalassemia (NTDT).\n* Pulmonary artery pressure (PAP) \\> 35 mmHg estimated by Doppler echocardiography at screening.\n* Able and willing to provide written informed consent.\n* On a stable standard-of-care regimen (e.g., chelation and/or hydroxyurea) per treating physician judgment.\n\nExclusion Criteria:\n\n* Age \\<18 years.\n* Refusal or inability to provide informed consent.\n* Hepatic dysfunction: ALT \\>3× upper limit of normal.\n* Renal dysfunction: serum creatinine \\>2× upper limit of normal.\n* Known hypersensitivity to L-glutamine.\n* Pregnancy or breastfeeding.\n* Use of amino-acid/protein supplements within the past 3 months.\n* History of other cardiac diseases associated with pulmonary hypertension (per investigator assessment).'}, 'identificationModule': {'nctId': 'NCT07210450', 'briefTitle': 'Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia', 'organization': {'class': 'OTHER', 'fullName': 'Mazandaran University of Medical Sciences'}, 'officialTitle': 'The Effect of Glutamine on Reducing Pulmonary Arterial Pressure in Non-transfusion-dependent Thalassemia Patients: a Single Blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IR.MAZUMS.REC.1402.246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-Glutamine + Standard Care', 'description': 'Participants in this arm will receive oral L-glutamine at a dose of 0.1 g/kg/day for 60 days, in addition to their routine standard care for non-transfusion-dependent thalassemia', 'interventionNames': ['Drug: L-glutamine']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care Alone', 'description': 'Standard care may include iron chelation therapy and/or hydroxyurea as prescribed by the treating physician.'}], 'interventions': [{'name': 'L-glutamine', 'type': 'DRUG', 'description': "Oral L-glutamine powder, administered at a dose of 0.1 g/kg/day for 60 days in adult patients with non-transfusion-dependent thalassemia (NTDT). The supplement is given in addition to each participant's standard care regimen (e.g., hydroxyurea or iron chelation therapy, as clinically indicated).", 'armGroupLabels': ['L-Glutamine + Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4815738477', 'city': 'Sari', 'state': 'Mazandaran', 'country': 'Iran', 'facility': "Bu'Ali Sina Hospital", 'geoPoint': {'lat': 36.56332, 'lon': 53.06009}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data will not be shared because of the small sample size, the single-center design, and the need to protect patient privacy. Only aggregated results will be reported in publications or presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mazandaran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatrician', 'investigatorFullName': 'Rozita Gorzin', 'investigatorAffiliation': 'Mazandaran University of Medical Sciences'}}}}