NCT05097365

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

Effect of Methyl-donor Nutrient Supplementation on Methylation Profile of Inflammatory-related Genes in Lupus Patients With Obesity: a Clinical Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-07-31
• Completion: 2026-12-31
• First posted: 2021-10-28
• Last updated: 2024-05-02

Locations

1 site across 1 country: Brazil