Lupus Erythematosus, Overweight and Obesity
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTVitamin B12 + folic acid supplementation
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.
DIETARY_SUPPLEMENTPlacebo supplementation
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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* SLE diagnosis * Female * In pre-menopausal period * Aged between 18 to 45 years * Patients that meet the classification criteria according to Systemic Lupus International Collaborating Clinics classification criteria (SLICC) * Patients with SLEDAI score ≤ 4 on Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) * Under prednisone treatment at a dosage \<10 mg/day * Under treatment with chloroquine at a stable dose * BMI \> 18,5 kg/m2
Exclusion criteria
* Current infection * Diabetes * Arterial hypertension * Smokers * Pregnancy * Anticoagulants use * Methotrexate use * Other autoimmune diseases * Current vitamin B12 or/and folic acid supplementation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on DNA methylation profile at 12 weeks | Baseline and 12 weeks | Percentage of DNA methylation level |
| Change from baseline on weight at 12 weeks | Baseline and 12 weeks | Weight in kilograms |
| Change from baseline on serum vitamin B12 concentrations at 12 weeks | Baseline and 12 weeks | Serum vitamin B12 concentrations in pg/mL |
| Change from baseline on serum folic acid concentrations at 12 weeks | Baseline and 12 weeks | Serum folic acid concentrations in ng/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on miR-21 expression at 12 weeks | Baseline and 12 weeks | Relative miR-21 expression |
| Change from baseline on miR-126 expression at 12 weeks | Baseline and 12 weeks | Relative miR-126 expression |
| Change from baseline on TNF-a gene expression at 12 weeks | Baseline and 12 weeks | Relative gene expression of TNF-a |
| Change from baseline on LEP gene expression at 12 weeks | Baseline and 12 weeks | Relative gene expression of LEP |
| Change from baseline on ADIPOQ gene expression at 12 weeks | Baseline and 12 weeks | Relative gene expression of ADIPOQ |
| Change from baseline on abdominal circumference at 12 weeks | Baseline and 12 weeks | Abdominal circumference in centimeters |
| Change from baseline on MTHFR gene expression at 12 weeks | Baseline and 12 weeks | Relative gene expression of MTHFR |
| Change from baseline on STAT3 gene expression at 12 weeks | Baseline and 12 weeks | Relative gene expression of STAT3 |
| Change from baseline on IL-6 gene expression at 12 weeks | Baseline and 12 weeks | Relative gene expression of IL-6 |
| Change from baseline on DNMT1 gene expression at 12 weeks | Baseline and 12 weeks | Relative gene expression of DNMT1 |
| Change from baseline on serum leptin concentrations at 12 weeks | Baseline and 12 weeks | Serum leptin concentration in ng/mL |
| Change from baseline on serum IL-6 concentrations at 12 weeks | Baseline and 12 weeks | Serum IL-6 concentration in ng/mL |
| Age of onset | Baseline | Units of Measure: years |
| Change from baseline on serum IL-2 concentrations at 12 weeks | Baseline and 12 weeks | Serum IL-2 concentration in ng/mL |
| Change from baseline on serum TNF-a concentrations at 12 weeks | Baseline and 12 weeks | Serum TNF-a concentration in ng/mL |
| Change from baseline on serum C-reactive protein concentrations at 12 weeks | Baseline and 12 weeks | Serum C-reactive protein concentration in ng/mL |
| Change from baseline on serum adipokines concentrations at 12 weeks | Baseline and 12 weeks | Serum adipokines concentration in ng/mL |
| Change from baseline on serum triglycerides concentrations at 12 weeks | Baseline and 12 weeks | Serum triglycerides concentration in mg/dL |
| Change from baseline on serum cholesterol concentrations at 12 weeks | Baseline and 12 weeks | Serum cholesterol concentrations in mg/dL |
| Change from baseline on serum glucose concentrations at 12 weeks | Baseline and 12 weeks | Serum glucose concentrations in mg/dL |
| Change from baseline on dietary intake at 12 weeks | Baseline and 12 weeks | Dietary intake in g and percentage |
| Change from baseline on fat mass at 12 weeks | Baseline and 12 weeks | Fat mass in kilograms |
| Change from baseline on fat free mass at 12 weeks | Baseline and 12 weeks | Fat free mass in kilograms |
| Change from baseline on body mass index at 12 weeks | Baseline and 12 weeks | Body mass index in kilograms/meters\^2 |
| Change from baseline on height at 12 weeks | Baseline and 12 weeks | Height in meters |
| Change from baseline on serum IL-17 concentrations at 12 weeks | Baseline and 12 weeks | Serum IL-17 concentration in ng/mL |
| Duration of disease since diagnosis | Baseline | Units of Measure: years |
| Change from baseline on miR-146 expression at 12 weeks | Baseline and 12 weeks | Relative miR-146 expression |
| Change from baseline on miR-181 expression at 12 weeks | Baseline and 12 weeks | Relative miR-181 expression |
Countries
Brazil
Outcome results
None listed