Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT05310760
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Vitamin C Supplementation in Treatment of Rickets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-02-08', 'releaseDate': '2023-06-09'}], 'estimatedResultsFirstSubmitDate': '2023-06-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D012279', 'term': 'Rickets'}], 'ancestors': [{'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'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-03-26', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets', 'timeFrame': 'After 1 month stating the trial', 'description': 'Measuring the clinical finding of rickets by history taking from parents (abnormal gait , delayed dentition, delayed milestones)'}, {'measure': 'Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets', 'timeFrame': 'After 1 month stating the trial', 'description': 'Measuring the anthropometric measures with correlation to the baseline ,these measures includes : Body mass index'}, {'measure': 'Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets', 'timeFrame': 'After 1 month stating the trial', 'description': 'Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.'}, {'measure': 'Laboratory follow up of rachitic children and infants', 'timeFrame': 'after 1 month from stating the trial', 'description': 'Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA'}, {'measure': 'Radiological assessment after treatment for bone healing', 'timeFrame': 'after 1 month from stating the trial', 'description': 'X-Ray of both knees , in A-P view to show metaphysis and epiphysis of both femur and tibia to assess the osteopenia, bone frying and bone cupping'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of therapeutic doses of vitamin C in clinical finding of rickets', 'timeFrame': 'after 3 month from stating the trial', 'description': 'Measuring the clinical finding of rickets by history taking from parents (abnormal gait , delayed dentition, delayed milestones)'}, {'measure': 'Effectiveness of therapeutic doses of vitamin C on anthropometric measures clinical finding of rickets', 'timeFrame': 'after 3 month from stating the trial', 'description': 'Measuring the clinical finding of rickets by anthropometric measures with correlation to the baseline ,these measures includes : Body mass index'}, {'measure': 'Effectiveness of therapeutic doses of vitamin C in clinical signs of rickets', 'timeFrame': 'after 3 month from stating the trial', 'description': 'Examination to monitor the other symptoms of rickets including bone tenderness , bone deformities , hypotonia.'}, {'measure': 'Laboratory follow up of rachitic children and infants', 'timeFrame': 'after 3 month from stating the trial', 'description': 'Follow up calcium , phosphorus , parathyroid hormone, vitamin D and bone mineralization (serum MID-Osteocalcin by ELIZA.'}, {'measure': 'Radiological assessment after treatment for bone healing', 'timeFrame': 'After 3 month from stating the trial', 'description': 'X-Ray of both knees , in A-P view to show metaphysis and epiphysis of both femur and tibia to assess the osteopenia, bone frying and bone cupping'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutritional Rickets', 'Vitamin C', 'Rickets', 'Bone Turnover', 'Osteocalcin'], 'conditions': ['Nutritional Rickets', 'Bone Turnover Rate Disorder']}, 'descriptionModule': {'briefSummary': 'Effectiveness of therapeutic dose of vitamin C in infants and children with nutritional rickets as an adjuvant therapy with vitamin D and calcium The study is two armed Randomized Control Trial, to validate the role of Vit C supplementation on bone turnover infants and children with nutritional rickets.', 'detailedDescription': "* Population of study \\& disease condition The study will include 88 infants and children with nutritional rickets\n* Study setting:\n\nThe patients will be recruited from out-patient clinic of Cairo University Children's Hospital.\n\n\\- Inclusion criteria: Any infant or child between 6 months and 3 years with nutritional rickets\n\n* Exclusion criteria:\n\n 1. Unwilling to participate in the study.\n 2. Non nutritional causes of rickets as hypoparathyroidism, renal causes, chronic liver disease, and malabsorption.\n 3. Children on vitamin C supplements above Recommended Daily allowance\n* Methodology in details:\n* History including age, sex, onset of manifestations, nutritional history, family history of similar condition, history of tetany or convulsion, motor development, drug intake, fractures, history of dentition, and manifestations of vitamin C deficiency (musculoskeletal pain, irritability, loss of appetite, petechiae, ecchymosis, gingival bleeding, alopecia, and poor wound healing) will be taken.\n* Examination including anthropometric measurements, limb deformities, anterior fontanelle, cranial sutures, teeth, and gingival mucosa.\n* Serum measurements of calcium, phosphorous, alkaline phosphate, Parathyroid hormone, and 25 hydroxy-vitamin D will be done at first visit then follow up of serum calcium, phosphorous and alkaline phosphatase after 4 and 12 weeks after starting the treatment.\n* Radiological investigation in the form of anterior view X-ray of the knee that reveals the metaphysis end and epiphysis of the femur and tibia will be done at first visit and follow up after 4 weeks.\n* Serum level of post treatment N-MID-osteocalcin detection (marker of bone turnover) \\[6\\] by ELIZA , Catalogue number E1499Hu Bioassay technology la laboratory England/China\n\nThe patient will be randomized 1:1 by computer randomization sequence into two groups (A, B). All patients will receive therapeutic dose of vitamin D (either single-day dose of 600,000 U or daily doses of 5000 U for 2-3 months) and oral elemental calcium according to Recommended Daily allowance . However, group A will receive oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months) in addition to the above-mentioned treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis:\n\n* Nutritional rickets in infants or children between 6 months and 3 years.\n* Normal liver and kidney functions.\n* The parents must be compliant to the clinic visits and the treatment doses.\n\nExclusion Criteria:\n\n* Unwilling to participate in the study.\n* Non nutritional causes of rickets as hypoparathyroidism, renal causes, chronic liver disease, and malabsorption.\n* Children on vitamin C supplements above RDA.'}, 'identificationModule': {'nctId': 'NCT05310760', 'briefTitle': 'Effectiveness of Vitamin C Supplementation in Treatment of Rickets', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effectiveness of Vitamin C Supplementation in Infants and Children Suffering of Nutritional Rickets', 'orgStudyIdInfo': {'id': 'MS-23-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin C receiving', 'description': 'Therapeutic doses of Vitamin C are added to rachitic children treatment', 'interventionNames': ['Drug: Vit C']}, {'type': 'NO_INTERVENTION', 'label': 'Non Vitamin C receiving', 'description': 'The traditional treatment of nutritional rickets'}], 'interventions': [{'name': 'Vit C', 'type': 'DRUG', 'description': 'Oral vitamin C (100 mg three times daily for one week then 100 mg once daily for 1-3 months)', 'armGroupLabels': ['Vitamin C receiving']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Faculty of Medicine ,Abo elrish Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Fatina Fadel, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Pediatrics Faculty of Medicine Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After publishing', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical and Chemical Pathology', 'investigatorFullName': 'Fatma Abdel Maksoud', 'investigatorAffiliation': 'Cairo University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-06-09', 'type': 'RELEASE'}, {'date': '2024-02-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Fatma Abdel Maksoud, Lecturer of Clinical and Chemical Pathology, Cairo University'}}}}