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
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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