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

NCT05097365 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-05-02

No results posted yet for this 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.

Conditions

  • Overweight and Obesity
  • Lupus Erythematosus

Interventions

DIETARY_SUPPLEMENT

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.

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.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-07-31
Completion
2026-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097365 on ClinicalTrials.gov