Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-29 @ 5:30 PM
Study NCT ID:
NCT02936895
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2016-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Index of Severity in Children (RISC)', 'timeFrame': 'through study completion, an average of 4 days', 'description': 'For determining severity of pneumonia, RISC (Respiratory Index of Severity in Children) scoring system was used, including oxygen saturation, chest retraction, wheezing and refusal to feed, and also contains standards growth (weight for age).'}], 'secondaryOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': 'through study completion, an average of 4 days', 'description': 'Duration of hospitalization of the patient'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'Childhood deaths from pneumonia is almost 2000 times higher in developing countries than in developed countries. In 1970, pneumonia was responsible for 9% of all deaths in children under 5 years. This rate was 2% in 2007.\n\nSome studies have shown that supplementing with vitamin D reduces disease of the respiratory tract infection. Some other studies have shown anti-inflammatory effect of vitamin D in cell lines. Studies about the role of vitamin D supplementation in pneumonia in children are inadequate to conclude about its role.\n\nThe aim of this study is to determine the efficacy of vitamin D supplementation in Respiratory Index of Severity in Children (RISC) hospitalized clinical outcomes of hospitalized patients with community-acquired pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Aged between 2 months to 6 years\n* Definite diagnosis of pneumonia\n\nExclusion criteria\n\n* Immunocompromised patients\n* Airway hypersensitivity or asthma\n* allergies\n* nasal polyps\n* Using inhaled medications to one month prior to the study\n* Receiving high doses of vitamin D\n* Avoiding to complete informed consent form'}, 'identificationModule': {'nctId': 'NCT02936895', 'briefTitle': 'Vitamin D Supplementation and Respiratory Index of Severity in Children (RISC) in Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Hormozgan University of Medical Sciences'}, 'officialTitle': 'The Effects of Vitamin D Supplementation in Respiratory Index of Severity in Children (RISC) of Hospitalized Patients With Community-acquired Pneumonia', 'orgStudyIdInfo': {'id': '188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D3 (Low dose)', 'description': 'vitamin D at a dose of 50,000 IU per day for 2 days', 'interventionNames': ['Drug: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (same size and shape) for 2 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'otherNames': ['cholecalciferol'], 'description': 'vitamin D at a dose of 50,000 IU per day for 2 days', 'armGroupLabels': ['Vitamin D3 (Low dose)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for 2 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79176', 'city': 'Bandar Abbas', 'state': 'Hormozgan', 'country': 'Iran', 'facility': 'Shahid Mohammadi hospital', 'geoPoint': {'lat': 27.1865, 'lon': 56.2808}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hormozgan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Hamidreza Mahboobi', 'investigatorAffiliation': 'Hormozgan University of Medical Sciences'}}}}