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

NCT ID: NCT05097365

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-12-31

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.

Conditions

Overweight and Obesity; Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Supplemented Normal Weight Group

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

Group Type: EXPERIMENTAL

Vitamin B12 + folic acid supplementation

Intervention Type: 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.

Supplemented Excess Body Weight Group

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

Group Type: EXPERIMENTAL

Vitamin B12 + folic acid supplementation

Intervention Type: 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.

Control Normal Weight Group

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

Group Type: PLACEBO_COMPARATOR

Placebo supplementation

Intervention Type: 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.

Control Excess Body Weight Group

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

Group Type: PLACEBO_COMPARATOR

Placebo supplementation

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Bruno Gualano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Univsersity of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39375179 (View on PubMed)

Other Identifiers

SLE and DNA methylation

Identifier Type: -

Identifier Source: org_study_id