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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C | Experimental | The patients were given a tablet containing Vitamin C 500 mg twice a day |
|
| Placebo | Placebo Comparator | The patients were given a placebo capsule with a similar color, shape, size and taste twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Dietary Supplement | The patients received vitamin C supplementation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 | To determine the effectiveness of adding vitamin C compared to placebo towards IL-6 levels concentration change in SLE patients. | From enrollment to the end of the treatment at 8 weeks |
| MEX-SLEDAI | To determine the effectiveness of adding vitamin C compared to placebo towards disease activity in SLE patients, measured with MEX-SLEDAI score | From enrollment to the end of the treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria
Drop-out Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammad Hoesin General Hospital | Palembang | South Sumatera | 30126 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12672194 | Background | 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. | |
| 15693087 | Background | 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. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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
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Triple (Participant, Care Provider, Investigator)
| Placebo |
| Dietary Supplement |
Patients received placebo capsules |
|
| 26170625 | Background | 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. |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |