Clinical trial

Methyl-donor Nutrient Supplementation and Methylation Profile in Lupus Patients With Obesity

Invitation only · Not applicable · 1 countries · Registry ID NCT05097365

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexFemale

Healthy volunteersNot accepted

ConditionOverweight and Obesity, Lupus Erythematosus

Full registry criteria

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

Treatments and study arms

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.

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.

Primary outcomes

Change from baseline on DNA methylation profile at 12 weeksBaseline and 12 weeks

Percentage of DNA methylation level

Change from baseline on weight at 12 weeksBaseline and 12 weeks

Weight in kilograms

Change from baseline on serum vitamin B12 concentrations at 12 weeksBaseline and 12 weeks

Serum vitamin B12 concentrations in pg/mL

Change from baseline on serum folic acid concentrations at 12 weeksBaseline and 12 weeks

Serum folic acid concentrations in ng/mL

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Univsersity of Sao Paulo🇧🇷 São Paulo, Brazil

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