Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT02993302
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}, {'id': 'C008088', 'term': 'alfacalcidol'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dyah_p_irawan@yahoo.com', 'phone': '62213907703', 'title': 'Dyah Purnamasari', 'organization': 'Dr. Cipto Mangunkusumo Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PTU + Oral 1α-D3', 'description': "patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\n1α-D3: patients were given PTU and 1α-D3", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PTU + Placebos', 'description': "patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\nPlacebos: patients were given PTU and placebos", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CD80 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTU + Oral 1α-D3', 'description': "patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\n1α-D3: patients were given PTU and 1α-D3"}, {'id': 'OG001', 'title': 'PTU + Placebos', 'description': "patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\nPlacebos: patients were given PTU and placebos"}], 'classes': [{'categories': [{'measurements': [{'value': '45.60', 'groupId': 'OG000', 'lowerLimit': '31.20', 'upperLimit': '139.36'}, {'value': '54.51', 'groupId': 'OG001', 'lowerLimit': '39.47', 'upperLimit': '69.55'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'CD206 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTU + Oral 1α-D3', 'description': "patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\n1α-D3: patients were given PTU and 1α-D3"}, {'id': 'OG001', 'title': 'PTU + Placebos', 'description': "patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\nPlacebos: patients were given PTU and placebos"}], 'classes': [{'categories': [{'measurements': [{'value': '54.08', 'spread': '23.46', 'groupId': 'OG000'}, {'value': '53.42', 'spread': '13.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Dendritic cells maturation levels were measured by the CD206', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'IL-12/IL-10 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTU + Oral 1α-D3', 'description': "patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\n1α-D3: patients were given PTU and 1α-D3"}, {'id': 'OG001', 'title': 'PTU + Placebos', 'description': "patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\nPlacebos: patients were given PTU and placebos"}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '8.01'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '3.40'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'fT4 Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTU + Oral 1α-D3', 'description': "patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\n1α-D3: patients were given PTU and 1α-D3"}, {'id': 'OG001', 'title': 'PTU + Placebos', 'description': "patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\nPlacebos: patients were given PTU and placebos"}], 'classes': [{'categories': [{'measurements': [{'value': '2.65', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'fT4 (free thyroxine)', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PTU + Oral 1α-D3', 'description': "patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\n1α-D3: patients were given PTU and 1α-D3"}, {'id': 'FG001', 'title': 'PTU + Placebos', 'description': "patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\nPlacebos: patients were given PTU and placebos"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "May 2014 - May 2015, Patients with Graves' disease who are still in hyperthyroid condition at the outpatient clinic of Endocrinology Department of Dr. Cipto Mangunkusumo Hospital in Jakarta, Indonesia."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PTU + Oral 1α-D3', 'description': "patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\n1α-D3: patients were given PTU and 1α-D3"}, {'id': 'BG001', 'title': 'PTU + Placebos', 'description': "patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis\n\nPlacebos: patients were given PTU and placebos"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.67', 'spread': '7.92', 'groupId': 'BG000'}, {'value': '38.15', 'spread': '9.34', 'groupId': 'BG001'}, {'value': '36', 'spread': '8.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of illness', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '266'}, {'value': '27', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '204'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '266'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'thyroid-stimulating hormone (TSH) levels', 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'BG000', 'lowerLimit': '0.01', 'upperLimit': '1.86'}, {'value': '0.01', 'groupId': 'BG001', 'lowerLimit': '0.01', 'upperLimit': '0.01'}, {'value': '0.01', 'groupId': 'BG002', 'lowerLimit': '0.01', 'upperLimit': '1.86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'µIU/l', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'free thyroxine (fT4) levels', 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'BG000', 'lowerLimit': '2.95', 'upperLimit': '7.77'}, {'value': '4.2', 'groupId': 'BG001', 'lowerLimit': '2.51', 'upperLimit': '7.77'}, {'value': '5.04', 'groupId': 'BG002', 'lowerLimit': '2.51', 'upperLimit': '7.77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'TSH receptor antibody (TRAb) levels', 'classes': [{'categories': [{'measurements': [{'value': '14.46', 'groupId': 'BG000', 'lowerLimit': '3.42', 'upperLimit': '87.74'}, {'value': '9.55', 'groupId': 'BG001', 'lowerLimit': '3.3', 'upperLimit': '55.4'}, {'value': '14.174', 'groupId': 'BG002', 'lowerLimit': '3.3', 'upperLimit': '87.74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'FULL_RANGE'}, {'title': 'Ca ion levels', 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '0.05', 'groupId': 'BG000'}, {'value': '1.13', 'spread': '0.06', 'groupId': 'BG001'}, {'value': '1.13', 'spread': '0.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vitamin 25-D3 levels', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '7.81', 'groupId': 'BG000'}, {'value': '25.55', 'spread': '5.56', 'groupId': 'BG001'}, {'value': '25', 'spread': '6.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2016-12-07', 'resultsFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2016-12-12', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-19', 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD80 Level', 'timeFrame': '1 year', 'description': 'Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)'}, {'measure': 'CD206 Level', 'timeFrame': '1 year', 'description': 'Dendritic cells maturation levels were measured by the CD206'}, {'measure': 'IL-12/IL-10 Ratio', 'timeFrame': '1 year', 'description': 'Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio'}, {'measure': 'fT4 Levels', 'timeFrame': '1 year', 'description': 'fT4 (free thyroxine)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vitamin D', "graves' disease", 'dendritic cells'], 'conditions': ['Graves Disease']}, 'referencesModule': {'references': [{'pmid': '10601966', 'type': 'BACKGROUND', 'citation': 'Tamura M, Matsuura B, Miyauchi S, Onji M. Dendritic cells produce interleukin-12 in hyperthyroid mice. Eur J Endocrinol. 1999 Dec;141(6):625-9. doi: 10.1530/eje.0.1410625.'}, {'pmid': '9521319', 'type': 'BACKGROUND', 'citation': 'Banchereau J, Steinman RM. Dendritic cells and the control of immunity. Nature. 1998 Mar 19;392(6673):245-52. doi: 10.1038/32588.'}, {'pmid': '18550825', 'type': 'BACKGROUND', 'citation': 'Liang S, Ristich V, Arase H, Dausset J, Carosella ED, Horuzsko A. Modulation of dendritic cell differentiation by HLA-G and ILT4 requires the IL-6--STAT3 signaling pathway. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8357-62. doi: 10.1073/pnas.0803341105. Epub 2008 Jun 11.'}, {'pmid': '21235536', 'type': 'BACKGROUND', 'citation': 'Inoue N, Watanabe M, Morita M, Tatusmi K, Hidaka Y, Akamizu T, Iwatani Y. Association of functional polymorphisms in promoter regions of IL5, IL6 and IL13 genes with development and prognosis of autoimmune thyroid diseases. Clin Exp Immunol. 2011 Mar;163(3):318-23. doi: 10.1111/j.1365-2249.2010.04306.x. Epub 2011 Jan 14.'}, {'pmid': '20400062', 'type': 'BACKGROUND', 'citation': "Khalilzadeh O, Anvari M, Esteghamati A, Momen-Heravi F, Mahmoudi M, Rashidi A, Amiri HM, Ranjbar M, Tabataba-Vakili S, Amirzargar A. The interleukin-1 family gene polymorphisms and Graves' disease. Ann Endocrinol (Paris). 2010 Sep;71(4):281-5. doi: 10.1016/j.ando.2010.01.005. Epub 2010 Apr 18."}, {'pmid': '10950112', 'type': 'BACKGROUND', 'citation': 'Croizet K, Rabilloud R, Kostrouch Z, Nicolas JF, Rousset B. Culture of dendritic cells from a nonlymphoid organ, the thyroid gland: evidence for TNFalpha-dependent phenotypic changes of thyroid-derived dendritic cells. Lab Invest. 2000 Aug;80(8):1215-25. doi: 10.1038/labinvest.3780129.'}, {'pmid': '21190445', 'type': 'BACKGROUND', 'citation': "Dedecjus M, Stasiolek M, Brzezinski J, Selmaj K, Lewinski A. Thyroid hormones influence human dendritic cells' phenotype, function, and subsets distribution. Thyroid. 2011 May;21(5):533-40. doi: 10.1089/thy.2010.0183. Epub 2010 Dec 29."}, {'pmid': '17729041', 'type': 'BACKGROUND', 'citation': 'Hughes GC, Clark EA. Regulation of dendritic cells by female sex steroids: relevance to immunity and autoimmunity. Autoimmunity. 2007 Sep;40(6):470-81. doi: 10.1080/08916930701464764.'}, {'pmid': '12429717', 'type': 'BACKGROUND', 'citation': 'Duperrier K, Farre A, Bienvenu J, Bleyzac N, Bernaud J, Gebuhrer L, Rigal D, Eljaafari A. Cyclosporin A inhibits dendritic cell maturation promoted by TNF-alpha or LPS but not by double-stranded RNA or CD40L. J Leukoc Biol. 2002 Nov;72(5):953-61.'}, {'pmid': '10812248', 'type': 'BACKGROUND', 'citation': 'Berer A, Stockl J, Majdic O, Wagner T, Kollars M, Lechner K, Geissler K, Oehler L. 1,25-Dihydroxyvitamin D(3) inhibits dendritic cell differentiation and maturation in vitro. Exp Hematol. 2000 May;28(5):575-83. doi: 10.1016/s0301-472x(00)00143-0.'}, {'pmid': '24482685', 'type': 'BACKGROUND', 'citation': 'Wahono CS, Rusmini H, Soelistyoningsih D, Hakim R, Handono K, Endharti AT, Kalim H, Widjajanto E. Effects of 1,25(OH)2D3 in immune response regulation of systemic lupus erithematosus (SLE) patient with hypovitamin D. Int J Clin Exp Med. 2014 Jan 15;7(1):22-31. eCollection 2014.'}, {'pmid': '23341164', 'type': 'BACKGROUND', 'citation': "Bartels LE, Jorgensen SP, Bendix M, Hvas CL, Agnholt J, Agger R, Dahlerup JF. 25-Hydroxy vitamin D3 modulates dendritic cell phenotype and function in Crohn's disease. Inflammopharmacology. 2013 Apr;21(2):177-86. doi: 10.1007/s10787-012-0168-y. Epub 2013 Jan 23."}, {'pmid': '23238772', 'type': 'BACKGROUND', 'citation': 'Agmon-Levin N, Theodor E, Segal RM, Shoenfeld Y. Vitamin D in systemic and organ-specific autoimmune diseases. Clin Rev Allergy Immunol. 2013 Oct;45(2):256-66. doi: 10.1007/s12016-012-8342-y.'}, {'pmid': '18782354', 'type': 'BACKGROUND', 'citation': "Zhou H, Xu C, Gu M. Vitamin D receptor (VDR) gene polymorphisms and Graves' disease: a meta-analysis. Clin Endocrinol (Oxf). 2009 Jun;70(6):938-45. doi: 10.1111/j.1365-2265.2008.03413.x. Epub 2008 Sep 8."}, {'type': 'BACKGROUND', 'citation': 'Budiyati AD, Setiyono A, Tarigan E and Wibowo H. The effect of alpha fetoprotein on NF-kB translocation in lipopolysaccharide induced monocyte-derived dendritic cell. Med J Indones. 2012; 21.'}, {'pmid': '20511058', 'type': 'BACKGROUND', 'citation': 'Hewison M. Vitamin D and the immune system: new perspectives on an old theme. Endocrinol Metab Clin North Am. 2010 Jun;39(2):365-79, table of contents. doi: 10.1016/j.ecl.2010.02.010.'}, {'pmid': '22776787', 'type': 'BACKGROUND', 'citation': 'Antico A, Tampoia M, Tozzoli R, Bizzaro N. Can supplementation with vitamin D reduce the risk or modify the course of autoimmune diseases? A systematic review of the literature. Autoimmun Rev. 2012 Dec;12(2):127-36. doi: 10.1016/j.autrev.2012.07.007. Epub 2012 Jul 7.'}, {'pmid': '10843185', 'type': 'BACKGROUND', 'citation': 'Hunt PJ, Marshall SE, Weetman AP, Bell JI, Wass JA, Welsh KI. Cytokine gene polymorphisms in autoimmune thyroid disease. J Clin Endocrinol Metab. 2000 May;85(5):1984-8. doi: 10.1210/jcem.85.5.6588.'}, {'pmid': '24374976', 'type': 'RESULT', 'citation': "Bartels LE, Bendix M, Hvas CL, Jorgensen SP, Agnholt J, Agger R, Dahlerup JF. Oral vitamin D3 supplementation reduces monocyte-derived dendritic cell maturation and cytokine production in Crohn's disease patients. Inflammopharmacology. 2014 Apr;22(2):95-103. doi: 10.1007/s10787-013-0197-1. Epub 2013 Dec 29."}, {'pmid': '20739336', 'type': 'RESULT', 'citation': 'Bartosik-Psujek H, Tabarkiewicz J, Pocinska K, Stelmasiak Z, Rolinski J. Immunomodulatory effects of vitamin D on monocyte-derived dendritic cells in multiple sclerosis. Mult Scler. 2010 Dec;16(12):1513-6. doi: 10.1177/1352458510379611. Epub 2010 Aug 25.'}, {'pmid': '23204220', 'type': 'RESULT', 'citation': 'Abou-Raya A, Abou-Raya S, Helmii M. The effect of vitamin D supplementation on inflammatory and hemostatic markers and disease activity in patients with systemic lupus erythematosus: a randomized placebo-controlled trial. J Rheumatol. 2013 Mar;40(3):265-72. doi: 10.3899/jrheum.111594. Epub 2012 Dec 1.', 'retractions': [{'pmid': '30504482', 'source': 'J Rheumatol. 2018 Dec;45(12):1713'}]}, {'pmid': '12050214', 'type': 'RESULT', 'citation': "Pani MA, Regulla K, Segni M, Hofmann S, Hufner M, Pasquino AM, Usadel KH, Badenhoop K. A polymorphism within the vitamin D-binding protein gene is associated with Graves' disease but not with Hashimoto's thyroiditis. J Clin Endocrinol Metab. 2002 Jun;87(6):2564-7. doi: 10.1210/jcem.87.6.8562."}, {'pmid': '22983830', 'type': 'RESULT', 'citation': "Yasuda T, Okamoto Y, Hamada N, Miyashita K, Takahara M, Sakamoto F, Miyatsuka T, Kitamura T, Katakami N, Kawamori D, Otsuki M, Matsuoka TA, Kaneto H, Shimomura I. Serum vitamin D levels are decreased in patients without remission of Graves' disease. Endocrine. 2013 Feb;43(1):230-2. doi: 10.1007/s12020-012-9789-6. Epub 2012 Sep 15. No abstract available."}, {'pmid': '9322804', 'type': 'RESULT', 'citation': "Kawakami-Tani T, Fukawa E, Tanaka H, Abe Y, Makino I. Effect of 1 alpha-hydroxyvitamin D3 on serum levels of thyroid hormones in hyperthyroid patients with untreated Graves' disease. Metabolism. 1997 Oct;46(10):1184-8. doi: 10.1016/s0026-0495(97)90214-6."}, {'type': 'RESULT', 'citation': "D Purnamasari PS, S Djauzi, S Setiati, A Harahap, J Prihartono. Effects of In Vitro 1,25 Dihydroxyvitamin D on Maturation of Dendritic Cells in Graves' Disease Patients. Asian J Pharm Clin Res. 2016; 9: 221-4"}, {'type': 'RESULT', 'citation': 'Handono K, Gani AA, Ekawati M and Wahono S. Serum level of vitamin D and autoantibodies level in systemic lupus erythematosus (SLE) patients. Journal of Pharmacy and Biological Sciences. 2012; 3: 16-20'}, {'pmid': '10427152', 'type': 'RESULT', 'citation': "Tamaru M, Matsuura B, Onji M. Increased levels of serum interleukin-12 in Graves' disease. Eur J Endocrinol. 1999 Aug;141(2):111-6. doi: 10.1530/eje.0.1410111."}, {'type': 'RESULT', 'citation': "D Purnamasari PS, S Djauzi. Sunlight-derived vitamin D affects interleukin-4 level, T helper 2 serum cytokines, in patients with Graves' disease: a prospective cohort study. Med J Indones. 2015; 24: 228-33"}]}, 'descriptionModule': {'briefSummary': "Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro 1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral 1α-D3 on DC maturation in GD patients.", 'detailedDescription': "Patients with Graves' disease were divided into two groups: groups receiving oral 1α-D3 in addition to propylthiouracil (PTU) and groups receiving placebos in addition to PTU. Comparison of DC maturation were performed before and after the oral 1α-D3. DC maturation was assessed based on the expression of DC markers (HLA-DR, CD80, CD40, CD83, CD14 and CD206) and the ratio of cytokines interleukin-12/IL-10."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Graves' disease and still have not gone into remission\n* Willing to participate in the research\n\nExclusion Criteria:\n\n* Pregnant patient\n* Suffered from severe liver disease\n* Suffered from severe kidney disease\n* Taking vitamin D substitution therapy\n* Suffered from another autoimmune disease\n* Suffered from malignancy"}, 'identificationModule': {'nctId': 'NCT02993302', 'briefTitle': "Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients", 'organization': {'class': 'OTHER', 'fullName': 'Dr Cipto Mangunkusumo General Hospital'}, 'officialTitle': "Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients", 'orgStudyIdInfo': {'id': 'RSCM/FKUI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PTU-Oral 1α-D3', 'description': "patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis", 'interventionNames': ['Drug: 1α-D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PTU-Placebos', 'description': "patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis", 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': '1α-D3', 'type': 'DRUG', 'otherNames': ['1α 25-dihydroxyvitamin d3', 'alfacalcidol'], 'description': 'patients were given PTU and 1α-D3', 'armGroupLabels': ['PTU-Oral 1α-D3']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'patients were given PTU and placebos', 'armGroupLabels': ['PTU-Placebos']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dyah Purnamasari, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indonesia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D', 'investigatorFullName': 'Dyah Purnamasari', 'investigatorAffiliation': 'Dr Cipto Mangunkusumo General Hospital'}}}}