Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT01170494
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2010-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004872', 'term': 'Ergocalciferols'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-29', 'studyFirstSubmitDate': '2010-07-25', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'area under the curve of 25 OH vitamin D level', 'timeFrame': '140 days', 'description': 'area under the curve of total 25 OH vitamin D level from day 1 to 140'}], 'secondaryOutcomes': [{'measure': 'Cmax of 25 OH vitamin D', 'timeFrame': '140 days', 'description': 'Cmax of total 25 OH vitamin D over the treatment period of 140 days'}, {'measure': 'Tmax of 25 OH vitamin D level', 'timeFrame': '140 days', 'description': 'Tmax of total 25 OH vitamin D over the treatment period of 140 days'}, {'measure': 'area under the curve of vitamin D level', 'timeFrame': '140 days', 'description': 'area under the curve of total vitamin D level over 140 days'}, {'measure': 'incidence of hypercalcemia', 'timeFrame': '140 days'}, {'measure': 'incidence of hypercalciuria', 'timeFrame': '140 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '28231782', 'type': 'DERIVED', 'citation': 'Hammami MM, Yusuf A. Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. BMC Endocr Disord. 2017 Feb 24;17(1):12. doi: 10.1186/s12902-017-0163-9.'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.\n\nThe investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.\n* 25 OH vitamin D level between 20 to 50 nmol/L."}, 'identificationModule': {'nctId': 'NCT01170494', 'briefTitle': 'Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RAC 2101041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'D2 2000 IU daily', 'interventionNames': ['Drug: ergocalciferol 2000 IU orally, daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D3 2000 IU daily', 'interventionNames': ['Drug: cholecalciferol 2000 IU orally daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D2 1000 IU + D3 1000 IU daily', 'interventionNames': ['Drug: ergocal1000 IU & cholecal 1000 IU orally daily']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D2 25000 IU Q2wk', 'interventionNames': ['Drug: ergocalciferol 25000 IU oraly every 2 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D3 25000 IU Q2wk', 'interventionNames': ['Drug: Cholecalciferol 25000 IU orally every 2 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D2 50000 IU Q4wk', 'interventionNames': ['Drug: ergocalciferol 50000 IU orally every 4 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D3 50000 IU Q4wk', 'interventionNames': ['Drug: Cholecalciferol 50000 orally every 4 weeks']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo daily', 'interventionNames': ['Drug: placebo orally everyday']}], 'interventions': [{'name': 'ergocalciferol 2000 IU orally, daily', 'type': 'DRUG', 'otherNames': ['ergocalciferol'], 'description': 'ergocalciferol 2000 IU orally, daily', 'armGroupLabels': ['D2 2000 IU daily']}, {'name': 'ergocalciferol 25000 IU oraly every 2 weeks', 'type': 'DRUG', 'otherNames': ['ergocalciferol'], 'description': 'ergocalciferol 25000 IU oraly every 2 weeks', 'armGroupLabels': ['D2 25000 IU Q2wk']}, {'name': 'ergocalciferol 50000 IU orally every 4 weeks', 'type': 'DRUG', 'otherNames': ['ergocalciferol'], 'description': 'ergocalciferol 50000 IU orally every 4 weeks', 'armGroupLabels': ['D2 50000 IU Q4wk']}, {'name': 'ergocal1000 IU & cholecal 1000 IU orally daily', 'type': 'DRUG', 'otherNames': ['ergocalciferol and cholecalciferol'], 'description': 'ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day', 'armGroupLabels': ['D2 1000 IU + D3 1000 IU daily']}, {'name': 'cholecalciferol 2000 IU orally daily', 'type': 'DRUG', 'otherNames': ['cholecalciferol'], 'description': 'cholecalciferol 2000 IU orally everyday', 'armGroupLabels': ['D3 2000 IU daily']}, {'name': 'Cholecalciferol 25000 IU orally every 2 weeks', 'type': 'DRUG', 'otherNames': ['Cholecalciferol'], 'description': 'Cholecalciferol 25000 IU orally every 2 weeks', 'armGroupLabels': ['D3 25000 IU Q2wk']}, {'name': 'Cholecalciferol 50000 orally every 4 weeks', 'type': 'DRUG', 'otherNames': ['Cholecalciferol'], 'description': 'Cholecalciferol 50000 orally every 4 weeks', 'armGroupLabels': ['D3 50000 IU Q4wk']}, {'name': 'placebo orally everyday', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'placebo orally everyday', 'armGroupLabels': ['placebo daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11211', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & research Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Muhammad M Hammami, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Faisal Specialist Hospital & Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Department of Clinical Studies & Empirical Ethics', 'investigatorFullName': 'Muhammad Maher Hammami', 'investigatorAffiliation': 'King Faisal Specialist Hospital & Research Center'}}}}