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Dietary supplementation with methyl donors has been demonstrated to increase DNA methylation in leucocytes whereas a limited dietary intake of methyl donors was associated with DNA hypomethylation. Considering SLE disease, previously study showed that high doses of vitamin B6 and folate were associated with less severe SLE. Furthermore, some evidences reported a relatively high incidence of decreased serum B12 levels in rheumatic patients. This led to the suggestion that diets rich in methyl group donors could have beneficial effects on SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemented Normal Weight Group | Experimental | Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive supplementation. |
|
| Supplemented Excess Body Weight Group | Experimental | Patients with excess body weight (BMI > 25 kg/m²) that will receive supplementation. |
|
| Control Normal Weight Group | Placebo Comparator | Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive placebo. |
|
| Control Excess Body Weight Group | Placebo Comparator | Patients with excess body weight (BMI > 25 kg/m²) that will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B12 + folic acid supplementation | Dietary Supplement | A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a vitamin B12 and folic acid supplementation, in addition to the usual therapy. The dietary supplementation will be by capsules, which will content 400 mcg of folic acid and 2000 mcg of vitamin B12 each. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on DNA methylation profile at 12 weeks | Percentage of DNA methylation level | Baseline and 12 weeks |
| Change from baseline on weight at 12 weeks | Weight in kilograms | Baseline and 12 weeks |
| Change from baseline on serum vitamin B12 concentrations at 12 weeks | Serum vitamin B12 concentrations in pg/mL | Baseline and 12 weeks |
| Change from baseline on serum folic acid concentrations at 12 weeks | Serum folic acid concentrations in ng/mL | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Age of onset | Units of Measure: years | Baseline |
| Duration of disease since diagnosis | Units of Measure: years | Baseline |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univsersity of Sao Paulo | São Paulo | 05508-030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41666998 | Derived | Carvalho LM, da Mota JCNL, Ribeiro AA, Souza LL, Sposeto RB, Pinhel MAS, Nonino CB, Costa-Fraga N, Crujeiras AB, Izquierdo AG, Diaz-Lagares A, Hounkpe BW, Borba EF, Gualano B, Nicoletti CF. Epigenetic and metabolic signatures in systemic lupus erythematous: The impact of excess body weight on adipose tissue DNA methylation profile. Genomics. 2026 Mar;118(2):111217. doi: 10.1016/j.ygeno.2026.111217. Epub 2026 Feb 8. | |
| 41484640 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 15, 2026 | |
| Reset | Feb 2, 2026 | |
| Release | Feb 3, 2026 | |
| Reset | Feb 20, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 15, 2026 | Feb 2, 2026 | |||
| Feb 3, 2026 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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|
| Placebo supplementation | Dietary Supplement | A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a placebo supplementation.The placebo and vitamin B12 + folic acid supplement will be indistinguishable in terms of taste, smell, and appearance. |
|
| Change from baseline on miR-146 expression at 12 weeks | Relative miR-146 expression | Baseline and 12 weeks |
| Change from baseline on miR-181 expression at 12 weeks | Relative miR-181 expression | Baseline and 12 weeks |
| Change from baseline on miR-21 expression at 12 weeks | Relative miR-21 expression | Baseline and 12 weeks |
| Change from baseline on miR-126 expression at 12 weeks | Relative miR-126 expression | Baseline and 12 weeks |
| Change from baseline on TNF-a gene expression at 12 weeks | Relative gene expression of TNF-a | Baseline and 12 weeks |
| Change from baseline on LEP gene expression at 12 weeks | Relative gene expression of LEP | Baseline and 12 weeks |
| Change from baseline on ADIPOQ gene expression at 12 weeks | Relative gene expression of ADIPOQ | Baseline and 12 weeks |
| Change from baseline on MTHFR gene expression at 12 weeks | Relative gene expression of MTHFR | Baseline and 12 weeks |
| Change from baseline on STAT3 gene expression at 12 weeks | Relative gene expression of STAT3 | Baseline and 12 weeks |
| Change from baseline on IL-6 gene expression at 12 weeks | Relative gene expression of IL-6 | Baseline and 12 weeks |
| Change from baseline on DNMT1 gene expression at 12 weeks | Relative gene expression of DNMT1 | Baseline and 12 weeks |
| Change from baseline on serum leptin concentrations at 12 weeks | Serum leptin concentration in ng/mL | Baseline and 12 weeks |
| Change from baseline on serum IL-6 concentrations at 12 weeks | Serum IL-6 concentration in ng/mL | Baseline and 12 weeks |
| Change from baseline on serum IL-17 concentrations at 12 weeks | Serum IL-17 concentration in ng/mL | Baseline and 12 weeks |
| Change from baseline on serum IL-2 concentrations at 12 weeks | Serum IL-2 concentration in ng/mL | Baseline and 12 weeks |
| Change from baseline on serum TNF-a concentrations at 12 weeks | Serum TNF-a concentration in ng/mL | Baseline and 12 weeks |
| Change from baseline on serum C-reactive protein concentrations at 12 weeks | Serum C-reactive protein concentration in ng/mL | Baseline and 12 weeks |
| Change from baseline on serum adipokines concentrations at 12 weeks | Serum adipokines concentration in ng/mL | Baseline and 12 weeks |
| Change from baseline on serum triglycerides concentrations at 12 weeks | Serum triglycerides concentration in mg/dL | Baseline and 12 weeks |
| Change from baseline on serum cholesterol concentrations at 12 weeks | Serum cholesterol concentrations in mg/dL | Baseline and 12 weeks |
| Change from baseline on serum glucose concentrations at 12 weeks | Serum glucose concentrations in mg/dL | Baseline and 12 weeks |
| Change from baseline on dietary intake at 12 weeks | Dietary intake in g and percentage | Baseline and 12 weeks |
| Change from baseline on abdominal circumference at 12 weeks | Abdominal circumference in centimeters | Baseline and 12 weeks |
| Change from baseline on fat mass at 12 weeks | Fat mass in kilograms | Baseline and 12 weeks |
| Change from baseline on fat free mass at 12 weeks | Fat free mass in kilograms | Baseline and 12 weeks |
| Change from baseline on body mass index at 12 weeks | Body mass index in kilograms/meters^2 | Baseline and 12 weeks |
| Change from baseline on height at 12 weeks | Height in meters | Baseline and 12 weeks |
| Derived |
| da Mota JCNL, Carvalho LM, Souza LL, Ribeiro AA, Pinhel MAS, Nonino CB, Godoy AL, Borba EF, Hounkpe BW, Gualano B, Nicoletti CF. Nutritional status-dependent DNA methylation modifications on adipose tissue in systemic lupus erythematosus women following folic acid and vitamin B12 supplementation: a randomized double-blind placebo-controlled trial. Clin Epigenetics. 2026 Jan 3;18(1):21. doi: 10.1186/s13148-025-02041-5. |
| 39375179 | Derived | da Mota JCNL, Carvalho LM, Ribeiro AA, Souza LL, Borba EF, Roschel H, Gualano B, Nicoletti CF. Methyl-donor supplementation in women with systemic lupus erythematosus with different nutritional status: the protocol for a randomised, double-blind, placebo-controlled trial. Lupus Sci Med. 2024 Oct 7;11(2):e001279. doi: 10.1136/lupus-2024-001279. |
| Feb 20, 2026 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |