Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2026-03-10 @ 8:06 PM
Study NCT ID:
NCT02550912
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2015-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D066248', 'term': 'High Fructose Corn Syrup'}], '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'}, {'id': 'D000073417', 'term': 'Dietary Sugars'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D064427', 'term': 'Nutritive Sweeteners'}, {'id': 'D013549', 'term': 'Sweetening Agents'}, {'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2015-09-12', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)', 'timeFrame': 'At baseline, 12 weeks ,24 weeks'}, {'measure': 'Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)', 'timeFrame': 'At baseline, 12 weeks ,24 weeks'}], 'secondaryOutcomes': [{'measure': 'Effect of vitamin D on calcium level', 'timeFrame': 'At baseline, 12 weeks ,24 weeks'}, {'measure': 'Effect of vitamin D on phosphorous level', 'timeFrame': 'At baseline, 12 weeks ,24 weeks'}, {'measure': 'Effect of vitamin D on alkaline phosphatase level', 'timeFrame': 'At baseline,12 weeks ,24 weeks'}, {'measure': 'Effect of vitamin D on parathyroid hormone level', 'timeFrame': 'At baseline,12 weeks ,24 weeks'}, {'measure': 'Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)', 'timeFrame': 'At baseline, 12 weeks ,24 weeks'}, {'measure': 'Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)', 'timeFrame': 'At baseline, 12 weeks ,24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Autism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.', 'detailedDescription': 'Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism\n\nExclusion Criteria:\n\n* Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study."}, 'identificationModule': {'nctId': 'NCT02550912', 'briefTitle': 'A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children', 'orgStudyIdInfo': {'id': 'PhD(NO.18)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D group', 'description': 'Patients will receive vitamin D drug with generic name: V drops manufactured by Medical Union Pharmaceuticals, Egypt Dosage form: liquid drops Dosage, frequency, and Duration:1000 international units per day for 3 months then 1000 international units per 25 pounds per day for another 3 months.', 'interventionNames': ['Drug: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'otherNames': ['vitamin D drops'], 'description': 'vitamin D drops for paediatrics', 'armGroupLabels': ['Vitamin D group']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['glucose syrup'], 'description': 'glucose syrup with same taste and color to vitamin D3 drops', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Pharmacy AinShams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'sarah f mohamed fahmy, masters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant lecturer clinical pharmacy ainshams university'}, {'name': 'nagwa A sabri, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor in clinical pharmacy Ainshams university'}, {'name': 'manal H elhamamsy, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor in clinical pharmacy Ainshams university'}, {'name': 'mohamed A elsawi, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor in pediatrics and genetics ainshams university'}, {'name': 'osama k zaki, consultant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'medical consultant in paediatrics and genetics unit ainshams university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer in clinical pharmacy', 'investigatorFullName': 'Sarah Farid Mohamed Fahmy', 'investigatorAffiliation': 'Ain Shams University'}}}}