Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-08 @ 6:48 PM
Study NCT ID:
NCT01688102
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2012-09-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D014466', 'term': 'Ultraviolet Rays'}], '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': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D013472', 'term': 'Sunlight'}, {'id': 'D014887', 'term': 'Weather'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mponda@rockefeller.edu', 'phone': '212-327-7631', 'title': 'Dr. Manish Ponda', 'organization': 'The Rockefeller University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed', 'otherNumAtRisk': 60, 'otherNumAffected': 7, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes', 'otherNumAtRisk': 58, 'otherNumAffected': 21, 'seriousNumAtRisk': 58, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Skin erythema/burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'GI Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Skin dryness/irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Constipation/Hemmorhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Hip Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in LDL Cholesterol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months or last observation carried forward (minimum 2 months)', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '22', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '18.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months or last observation carried forward (minimum 2 months)', 'description': 'Change in Total Cholesterol', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months or last observation carried forward (minimum 2 months)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '35.4', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '42.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline 6 months or last observation carried forward (minimum 2 months)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in C Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '1.88', 'spread': '6.87', 'groupId': 'OG000'}, {'value': '-.11', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analyzed are only for those who completed 6 months of therapy'}, {'type': 'SECONDARY', 'title': 'Change in 25(OH)D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '18.7', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline vs. 6 months', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data only for those who completed 6 months of therapy'}, {'type': 'SECONDARY', 'title': 'Change in Serum Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '.09', 'spread': '.35', 'groupId': 'OG000'}, {'value': '.07', 'spread': '.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline vs. 6 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Parathyroid Hormone (PTH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '-5', 'spread': '19', 'groupId': 'OG000'}, {'value': '-9', 'spread': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline vs.6 months', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Correlation Between Change in LDL Cholesterol and Change in Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'groupId': 'OG000'}, {'value': '.16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months', 'description': 'The Correlation between change in LDL cholesterol and change in serum calcium', 'unitOfMeasure': 'Pearson correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Correlation Between Change in LDL Cholesterol and Change in PTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '-.01', 'groupId': 'OG000'}, {'value': '.18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months', 'unitOfMeasure': 'Pearson correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gene Expression Changes in Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'title': 'Interferon-alpha response', 'categories': [{'measurements': [{'value': '4.14', 'groupId': 'OG000'}, {'value': '-4.05', 'groupId': 'OG001'}]}]}, {'title': 'Interferon-gamma response', 'categories': [{'measurements': [{'value': '3.41', 'groupId': 'OG000'}, {'value': '-4.86', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline vs. 2 months', 'description': 'Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.', 'unitOfMeasure': 'GSEA Normalized Enrichment Score', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gene Expression Changes in Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'OG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'classes': [{'title': 'Interferon-alpha response', 'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000'}, {'value': '-2.43', 'groupId': 'OG001'}]}]}, {'title': 'Interferon-gamma response', 'categories': [{'measurements': [{'value': '2.12', 'groupId': 'OG000'}, {'value': '-2.00', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline vs. 2 months', 'description': 'Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.', 'unitOfMeasure': 'GSEA Normalized Enrichment Score', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'FG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.\n\nOral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed'}, {'id': 'BG001', 'title': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.\n\nUltraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '12', 'groupId': 'BG000'}, {'value': '39', 'spread': '12', 'groupId': 'BG001'}, {'value': '42', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-06', 'studyFirstSubmitDate': '2012-09-12', 'resultsFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2012-09-14', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-02', 'studyFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation Between Change in LDL Cholesterol and Change in Calcium', 'timeFrame': '2 months', 'description': 'The Correlation between change in LDL cholesterol and change in serum calcium'}, {'measure': 'Correlation Between Change in LDL Cholesterol and Change in PTH', 'timeFrame': '2 months'}, {'measure': 'Gene Expression Changes in Peripheral Blood', 'timeFrame': 'baseline vs. 2 months', 'description': 'Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.'}, {'measure': 'Gene Expression Changes in Skin', 'timeFrame': 'baseline vs. 2 months', 'description': 'Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.'}], 'primaryOutcomes': [{'measure': 'Change in LDL Cholesterol Level', 'timeFrame': 'baseline and 6 months or last observation carried forward (minimum 2 months)'}], 'secondaryOutcomes': [{'measure': 'Change in Total Cholesterol', 'timeFrame': 'baseline and 6 months or last observation carried forward (minimum 2 months)', 'description': 'Change in Total Cholesterol'}, {'measure': 'Change in HDL Cholesterol', 'timeFrame': 'baseline and 6 months or last observation carried forward (minimum 2 months)'}, {'measure': 'Change in Triglycerides', 'timeFrame': 'baseline 6 months or last observation carried forward (minimum 2 months)'}, {'measure': 'Change in C Reactive Protein', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Change in 25(OH)D', 'timeFrame': 'baseline vs. 6 months'}, {'measure': 'Change in Serum Calcium', 'timeFrame': 'baseline vs. 6 months'}, {'measure': 'Change in Parathyroid Hormone (PTH)', 'timeFrame': 'baseline vs.6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '28228421', 'type': 'DERIVED', 'citation': 'Ponda MP, Liang Y, Kim J, Hutt R, Dowd K, Gilleaudeau P, Sullivan-Whalen MM, Rodrick T, Kim DJ, Barash I, Lowes MA, Breslow JL. A randomized clinical trial in vitamin D-deficient adults comparing replenishment with oral vitamin D3 with narrow-band UV type B light: effects on cholesterol and the transcriptional profiles of skin and blood. Am J Clin Nutr. 2017 May;105(5):1230-1238. doi: 10.3945/ajcn.116.150367. Epub 2017 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'Participants in this study will be randomized to receive either oral vitamin D pills OR ultraviolet light treatment. The investigators will compare how these two methods of raising vitamin D levels will affect cholesterol levels.', 'detailedDescription': 'Potential subjects will be screened for eligibility, including serum 25(OH)D levels \\<20ng/ml. Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000 units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks. Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be measured monthly. For participants with levels \\<35 ng/ml, additional doses of oral vitamin D3 or UV radiation will be administered.\n\nA subset of participants from both groups will participate in a skin biopsy cohort, where skin biopsies are obtained before and after 8 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Vitamin D 25-OH level \\< 20 ng/ml\n\nExclusion Criteria:\n\n1. Serum calcium \\> 10.5 mg/dl\n2. Serum phosphorus \\> 5.5 mg/dl\n3. Serum parathyroid hormone (PTH) level \\< 12 pg/ml\n4. LDL cholesterol \\> 190 mg/dl\n5. History of recent acute infection (within 1 month)\n6. Glomerular filtration rate(GFR) \\< 60 mL/min\n7. Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or alanine transferase (ALT) \\> 3x ULN)\n8. Current use of Vitamin D \\> 400 IU/day\n9. Current use of any statins, fibrates, niacin, or ezetimibe\n10. Current use of any medications affecting sensitivity to UV light\n11. Pregnancy (self-reported)\n12. Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study\n13. history of malignancy not in remission (\\> 6 months)\n14. History of malignant melanoma\n15. Participation in an investigational drug study within 30 days of the screening visit\n16. Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.\n17. History of any non-melanoma skin cancer'}, 'identificationModule': {'nctId': 'NCT01688102', 'briefTitle': 'The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile', 'organization': {'class': 'OTHER', 'fullName': 'Rockefeller University'}, 'officialTitle': 'The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile', 'orgStudyIdInfo': {'id': 'MPO-0787'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Vitamin D3', 'description': 'Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of oral vitamin D.', 'interventionNames': ['Dietary Supplement: Oral Vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultraviolet Light', 'description': 'Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \\<35 ng/ml, subjects will receive additional doses of narrow band UVB.', 'interventionNames': ['Radiation: Ultraviolet Light']}], 'interventions': [{'name': 'Oral Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': '50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed', 'armGroupLabels': ['Oral Vitamin D3']}, {'name': 'Ultraviolet Light', 'type': 'RADIATION', 'description': '16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes', 'armGroupLabels': ['Ultraviolet Light']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Rockefeller University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Manish Ponda, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Rockefeller University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rockefeller University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Investigation', 'investigatorFullName': 'Manish Ponda', 'investigatorAffiliation': 'Rockefeller University'}}}}