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

Plain-language summary

This study examines the effect of methyl-donor nutrient supplements such as vitamin B12 and folic acid, compared with placebo, on the methylation profile in patients with systemic lupus erythematosus and obesity. It enrolls pre-menopausal women aged 18-45 with a lupus diagnosis and low disease activity. This non-phase study is enrolling participants by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Enrolling by invitation

Sponsor

University of Sao Paulo

Intervention

Vitamin B12 + folic acid supplementation, Placebo supplementation

Start date

1/1/2022

Estimated completion

12/31/2026

Countries

Brazil

Related genes

Locations

• São Paulo, Brazil

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion criteria:

* 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 Criteria:

* Current infection
* Diabetes
* Arterial hypertension
* Smokers
* Pregnancy
* Anticoagulants use
* Methotrexate use
* Other autoimmune diseases
* Current vitamin B12 or/and folic acid supplementation