Lupus & antiphospholipid syndrome

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 MedPublished Protocol for a randomised controlled trial

Study context

Population
Women with systemic lupus erythematosus (SLE) and normal weight or excess body weight (classified by BMI); Clinical Hospital, School of Medicine, University of Sao Paulo, Brazil
Planned comparison
Folic acid 400 mcg plus vitamin B12 2000 mcg for 3 months vs placebo
Primary endpoint
DNA methylation profile in subcutaneous adipose tissue
Follow-up
3 months
Methodological detailsdouble-blind, placebo-controlled, stratified by nutritional status (normal weight or excess body weight), intention-to-treat and per-protocol analyses
  • Double-blind
  • Placebo-controlled
  • Stratified by nutritional status (normal weight or excess body weight)
  • Intention-to-treat and per-protocol analyses

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

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. Published 7 October 2024. doi:10.1136/lupus-2024-001279

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