Vitamin B12 and folic acid in adults with lupus and obesity
Tests vitamin B12 with folic acid against placebo in adults with lupus and obesity.
Plain-language title generated from the registry record
Registry title: Methyl-donor Nutrient Supplementation and Methylation Profile in Lupus Patients With Obesity
Key facts
- Where
- São Paulo, BrazilSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT05097365, who can take part
Where in Brazil
- Univsersity of Sao PauloSão Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Sao Paulo
- Trial code
- NCT05097365
- Record updated
- 2 May 2024
- Original description
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.Read full original descriptionShow less
Effect of Methyl-donor Nutrient Supplementation on Methylation Profile of Inflammatory-related Genes in Lupus Patients With Obesity: a Clinical Trial
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.
Inclusion: 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.
Exclusion: Current infection; Diabetes; Arterial hypertension; Other autoimmune diseases; Smokers; Pregnancy; Anticoagulants use; Methotrexate use; Current vitamin B12 or/and folic acid supplementation.