Vitamin 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.
Placebo 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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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