Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT07071220
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2025-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Vitamin C Supplementation on Serum IL-6 Levels and Disease Activity in Systemic Lupus Erythematosus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Triple (Participant, Care Provider, Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was The study was designed as a single-center double-blind randomized controlled clinical trial. Participants were randomized into two groups receiving Vitamin C or placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-6', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'To determine the effectiveness of adding vitamin C compared to placebo towards IL-6 levels concentration change in SLE patients.'}, {'measure': 'MEX-SLEDAI', 'timeFrame': 'From enrollment to the end of the treatment at 8 weeks', 'description': 'To determine the effectiveness of adding vitamin C compared to placebo towards disease activity in SLE patients, measured with MEX-SLEDAI score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['systemic lupus erythematosus', 'SLE', 'vitamin C', 'IL-6', 'Mex-SLEDAI', 'disease activity'], 'conditions': ['Systemic Lupus Erythematosus (SLE)']}, 'referencesModule': {'references': [{'pmid': '12672194', 'type': 'BACKGROUND', 'citation': 'Minami Y, Sasaki T, Arai Y, Kurisu Y, Hisamichi S. Diet and systemic lupus erythematosus: a 4 year prospective study of Japanese patients. J Rheumatol. 2003 Apr;30(4):747-54.'}, {'pmid': '15693087', 'type': 'BACKGROUND', 'citation': 'Tam LS, Li EK, Leung VY, Griffith JF, Benzie IF, Lim PL, Whitney B, Lee VW, Lee KK, Thomas GN, Tomlinson B. Effects of vitamins C and E on oxidative stress markers and endothelial function in patients with systemic lupus erythematosus: a double blind, placebo controlled pilot study. J Rheumatol. 2005 Feb;32(2):275-82.'}, {'pmid': '26170625', 'type': 'BACKGROUND', 'citation': "Ellulu MS, Rahmat A, Patimah I, Khaza'ai H, Abed Y. Effect of vitamin C on inflammation and metabolic markers in hypertensive and/or diabetic obese adults: a randomized controlled trial. Drug Des Devel Ther. 2015 Jul 1;9:3405-12. doi: 10.2147/DDDT.S83144. eCollection 2015."}]}, 'descriptionModule': {'briefSummary': 'The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards IL-6 levels and disease activity with the MEX-SLEDAI score in Systemic Lupus Erythematosus (SLE) patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited ≥ 18 years old SLE patients, with mild to moderate disease activity and did not consumed vitamin C 1 week prior to the trial study. Participants were randomized into two groups receiving vitamin C supplementation, or placebo. IL-6 levels and MEX-SLEDAI score were evaluated at the beginning and at the end of the 8 week trial for analysis.', 'detailedDescription': 'This research is a double blind randomized controlled trial study. The study subjects were 38 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received vitamin C supplementation twice daily for 8 weeks and the group that received placebo. Serum IL-6 and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients diagnosed with systemic lupus erythematosus with mild-moderate disease activity who are treated at the Allergy-Immunology Department of RSMH.\n2. Patients aged over 18 years.\n3. Willing to participate in the study by signing an informed consent form.\n\nExclusion Criteria\n\n1. Patients with other immune disorders, both autoimmune and immunocompromised conditions such as human immunodeficiency virus (HIV)\n2. Pregnant and breastfeeding patients.\n3. Patients with malignancies.\n4. Patients with chronic liver disorders.\n5. Patients with infectious diseases.\n6. Patients who consume supplements containing vitamin C.\n\nDrop-out Criteria\n\n1. Patients who discontinue vitamin C for more than 3 weeks.\n2. Death.\n3. Development of serious drug side effects, requiring discontinuation of the medication.\n4. Patients who are readmitted or experience symptom deterioration during the intervention period.\n5. Loss to follow-up.'}, 'identificationModule': {'nctId': 'NCT07071220', 'briefTitle': 'Efficacy of Vitamin C Supplementation on Serum IL-6 Levels and Disease Activity in Systemic Lupus Erythematosus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sriwijaya'}, 'officialTitle': 'The Efficacy of Vitamin C Supplementation on Serum IL-6 Levels and Disease Activity in Systemic Lupus Erythematosus Patients', 'orgStudyIdInfo': {'id': '04.03/DXVIII0608ETIK/237/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'The patients were given a tablet containing Vitamin C 500 mg twice a day', 'interventionNames': ['Dietary Supplement: Vitamin C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patients were given a placebo capsule with a similar color, shape, size and taste twice a day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The patients received vitamin C supplementation', 'armGroupLabels': ['Vitamin C']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients received placebo capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30126', 'city': 'Palembang', 'state': 'South Sumatera', 'country': 'Indonesia', 'facility': 'Mohammad Hoesin General Hospital', 'geoPoint': {'lat': -2.91673, 'lon': 104.7458}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sriwijaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Division of Allergy Immunology Faculty Member, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital', 'investigatorFullName': 'Yuniza', 'investigatorAffiliation': 'Universitas Sriwijaya'}}}}