Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-30 @ 1:27 AM
Study NCT ID:
NCT06274203
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2024-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Vitamin D Supplementation in Children With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum 25(OH)D level', 'timeFrame': 'up to 6 months', 'description': 'Serum 25(OH)D level change from baseline at 6 months'}], 'secondaryOutcomes': [{'measure': 'Bone mineral density (BMD)', 'timeFrame': 'up to 6 months', 'description': 'BMD was evaluated at the posterior-anterior spine, Z-scores were used to interpret the results, with Z-scores less than -2 standard deviation (SD) being regarded as abnormal'}, {'measure': 'Maximum handgrip strength (HGS)', 'timeFrame': 'up to 6 months', 'description': 'Hand grip power using a handheld dynamometer.'}, {'measure': 'Health related quality of life (HRQL)', 'timeFrame': 'up to 6 months', 'description': 'Health related quality of life (HRQL) assessed by HRQL questionnaires, The questionnaire was divided into eight subscales: physical function, role limitations resulting from physical health, bodily pain, general health perception, vitality, social function, role limitations resulting from emotional problems, and mental health. For each subscale: higher score indicated good health and ranged from 0 to 100.'}, {'measure': 'Serum concentrations of C reactive protein (CRP)', 'timeFrame': 'up to 6 months', 'description': 'Serum concentrations of inflammatory marker (CRP) level change from baseline'}, {'measure': 'Serum concentrations of Erythrocyte sedimentation rate (ESR)', 'timeFrame': 'up to 6 months', 'description': 'Serum concentrations of inflammatory marker (ESR) level change from baseline'}, {'measure': 'Safety reporting of any adverse events', 'timeFrame': 'up to 6 months', 'description': 'e.g. nausea, drowsiness, vomiting, loss of appetite, constipation, confusion, cardiac arrhythmias, renal failure, coma'}, {'measure': 'Safety measurements of serum Ca', 'timeFrame': 'at 3 and 6 months', 'description': 'serum Ca levels'}, {'measure': 'childhood health assessment', 'timeFrame': 'up to 6 months', 'description': 'Assessed by childhood health assessment questionnaire (CHAQ), There are four potential responses to each question: "without any difficulty" (score 0); "with some difficulty" (score 1); "with much difficulty" (score 2); and "unable to do" (score 3). A summary score known as CHAQ-DI/, which varies from 0 to 3, is calculated by averaging the highest score in each domain. For a CHAQ-DI score to be considered minimally clinically significant, it must be ≥ 0.75.'}, {'measure': 'Safety measurements of serum 25(OH)D levels', 'timeFrame': 'at 3 and 6 months', 'description': 'serum 25(OH)D levels'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease', 'Vitamin D Deficiency', 'Health Related Quality of Life', 'Hand Grip Strength', 'Bone Mineral Density']}, 'referencesModule': {'references': [{'pmid': '38743288', 'type': 'DERIVED', 'citation': 'Hanna D, Kamal DE, Fawzy HM, Abd Elkhalek R. Safety and efficacy of monthly high-dose vitamin D3 supplementation in children and adolescents with sickle cell disease. Eur J Pediatr. 2024 Aug;183(8):3347-3357. doi: 10.1007/s00431-024-05572-w. Epub 2024 May 14.'}]}, 'descriptionModule': {'briefSummary': 'Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with SCD (HbSS, hemoglobin sickle beta zero (HbSβ0) thalassemia genotype), aged ≤ 18 years old, male or female study participants who were at a steady state (≥ one month from blood transfusion and ≥ 14 days from any acute sickle complication as hospitalization for Vaso occlusive crisis (VOC) or acute chest syndrome (ACS)), stable Hb level near their usual baseline and stable dose of Hydroxyurea (HÚ) mg/kg for at least 90 days prior to enrollment.\n* A control group of 42 healthy age and sex-matching children\n\nExclusion Criteria:\n\n* SCD patients who are on chronic blood transfusion therapy\n* Comorbid chronic conditions\n* Use of medications known to interfere with calcium or vitamin D absorption or metabolism\n* Known hypercalcemia or vitamin D hypersensitivity\n* Use of vitamin D therapy to treat vitamin D deficiency or rickets\n* Urolithiasis, liver or renal impairment, and malabsorption disorders.\n* Obese children with body mass index (BMI) \\> 85th percentile for age and sex'}, 'identificationModule': {'nctId': 'NCT06274203', 'briefTitle': 'High Dose Vitamin D Supplementation in Children With Sickle Cell Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Safety and Efficacy of Monthly High-Dose Vitamin D3 Supplementation in Children and Adolescents With Sickle Cell Disease and Healthy Counter Parents', 'orgStudyIdInfo': {'id': '10584-2/5-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral vitamin D3', 'description': 'Monthly oral vitamin D3 dose (100,000 IU,150,000 IU, and 200,000 IU)', 'interventionNames': ['Drug: Vitamin D3']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'description': 'Subjects within SCD as well as healthy controls, received monthly oral vitamin D3 dose, for 6 months, according to the baseline status of vitamin D as follows: sufficient (\\>30 ng/mL): 100,000 IU, insufficient (20-29.9 ng/mL): 150,000 IU, and deficient (\\<20 ng/mL): 200,000 IU.', 'armGroupLabels': ['Oral vitamin D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Zagazig university', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of pediatric hematology and oncology', 'investigatorFullName': 'Diana Hanna Abdelmalek Hanna', 'investigatorAffiliation': 'Zagazig University'}}}}