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

NCT05097365 | Enrolling By Invitation

• 1 other identifier: SLE and DNA methylation
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change from baseline on DNA methylation profile at 12 weeks

  Percentage of DNA methylation level

  Baseline and 12 weeks

• Change from baseline on weight at 12 weeks

  Weight in kilograms

  Baseline and 12 weeks

• Change from baseline on serum vitamin B12 concentrations at 12 weeks

  Serum vitamin B12 concentrations in pg/mL

  Baseline and 12 weeks

• Change from baseline on serum folic acid concentrations at 12 weeks

  Serum folic acid concentrations in ng/mL

  Baseline and 12 weeks

Secondary Outcomes (29)

• Age of onset

  Baseline

• Duration of disease since diagnosis

  Baseline

• Change from baseline on miR-146 expression at 12 weeks

  Baseline and 12 weeks

• Change from baseline on miR-181 expression at 12 weeks

  Baseline and 12 weeks

• Change from baseline on miR-21 expression at 12 weeks

  Baseline and 12 weeks

Study Arms (4)

Supplemented Normal Weight Group

EXPERIMENTAL

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

Dietary Supplement: Vitamin B12 + folic acid supplementation

Supplemented Excess Body Weight Group

EXPERIMENTAL

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

Dietary Supplement: Vitamin B12 + folic acid supplementation

Control Normal Weight Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplementation

Control Excess Body Weight Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplementation

Interventions

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.

Supplemented Excess Body Weight Group; Supplemented Normal Weight Group

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.

Control Excess Body Weight Group; Control Normal Weight Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current infection
• Diabetes
• Arterial hypertension
• Smokers
• Pregnancy
• Anticoagulants use
• Methotrexate use
• Other autoimmune diseases
• Current vitamin B12 or/and folic acid supplementation

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Univsersity of Sao Paulo

São Paulo, 05508-030, Brazil

Location

Related Publications (2)

• da Mota JCNL, Carvalho LM, Souza LL, Ribeiro AA, Pinhel MAS, Nonino CB, Godoy AL, Borba EF, Hounkpe BW, Gualano B, Nicoletti CF. Nutritional status-dependent DNA methylation modifications on adipose tissue in systemic lupus erythematosus women following folic acid and vitamin B12 supplementation: a randomized double-blind placebo-controlled trial. Clin Epigenetics. 2026 Jan 3. doi: 10.1186/s13148-025-02041-5. Online ahead of print.

  PMID: 41484640 DERIVED

• 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.

  PMID: 39375179 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: October 28, 2021
• Study Start: January 1, 2022
• Primary Completion: July 31, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

BR (1)