NCT05097365Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 2 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 10 Aug 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Jul 2022
- Lead sponsor
- University of Sao Paulo
- Diseases
- Obesity
- NCT number
- NCT05097365
What you commit to
- Study type: Interventional
- Planned participants: 51
- From 1 Jan 2022 to the primary completion date, 31 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current infection
- Diabetes
- Arterial hypertension
- Other autoimmune diseases
Other
- Smokers
- Pregnancy
- Anticoagulants use
- Methotrexate use
- Current vitamin B12 or/and folic acid supplementation
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univsersity of Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
Related publications
- Epigenetic and metabolic signatures in systemic lupus erythematous: The impact of excess body weight on adipose tissue DNA methylation profile.Genomics · 2026 · PMID 41666998
- Nutritional status-dependent DNA methylation modifications on adipose tissue in systemic lupus erythematosus women following folic acid and vitamin B12 supplementation: a randomized double-blind placebo-controlled trial.Clin Epigenetics · 2026 · PMID 41484640
This page is information, not medical advice. Discuss any trial with your doctor.