Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards TNF-α 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. TNF-α levels and MEX-SLEDAI score were evaluated at the beginning and at the end of the 8 week trial for analysis.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|
| MEX-SLEDAI score | 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 |
| TNF-α | To determine the effectiveness of adding vitamin C compared to placebo towards TNF-α levels concentration change in SLE patients. | From enrollment to the end of the treatment at 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria
Drop-out Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammad Hoesin General Hospital | Palembang | South Sumatera | 30126 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kong EH, Ma SY, Jeong JY, Kim KH. Effects of L-ascorbic acid on the production of pro-inflammatory and anti-inflammatory cytokines in C57BL/6 mouse splenocytes. KMJ. 2015 Jan 20;30(1):41-9. | ||
| 32793202 | Background | Islam MA, Khandker SS, Kotyla PJ, Hassan R. Immunomodulatory Effects of Diet and Nutrients in Systemic Lupus Erythematosus (SLE): A Systematic Review. Front Immunol. 2020 Jul 22;11:1477. doi: 10.3389/fimmu.2020.01477. eCollection 2020. |
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
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
Not provided
Not provided
Triple (Participant, Care Provider, Investigator)
| Placebo |
| Dietary Supplement |
Patients received placebo capsules |
|
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |