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

University of Sao Paulo

Status: Invitation-only

Conditions: Overweight and Obesity; Lupus Erythematosus

Treatments: Dietary Supplement: Placebo supplementation; Dietary Supplement: Vitamin B12 + folic acid supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05097365

SLE and DNA methylation

Details and patient eligibility

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.

Enrollment: 51 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 4 patient groups, including a placebo group

Supplemented Normal Weight Group

Experimental group

Description:

Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive supplementation.

Treatment:

Dietary Supplement: Vitamin B12 + folic acid supplementation

Supplemented Excess Body Weight Group

Experimental group

Description:

Patients with excess body weight (BMI \> 25 kg/m²) that will receive supplementation.

Treatment:

Dietary Supplement: Vitamin B12 + folic acid supplementation

Control Normal Weight Group

Placebo Comparator group

Description:

Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive placebo.

Treatment:

Dietary Supplement: Placebo supplementation

Control Excess Body Weight Group

Placebo Comparator group

Description:

Patients with excess body weight (BMI \> 25 kg/m²) that will receive placebo.

Treatment:

Dietary Supplement: Placebo supplementation