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Enrolling by Invitation

NCT Number: NCT05097365

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Lupus Erythematosus Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Univsersity of Sao Paulo

São Paulo, 05508-030, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B12 + folic acid supplementation

Dietary Supplement

A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a vitamin B12 and folic acid supplementation, in addition to the usual therapy. The dietary supplementation will be by capsules, which will content 400 mcg of folic acid and 2000 mcg of vitamin B12 each.

Placebo supplementation

Dietary Supplement

A 12 weeks parallel-group randomised controlled trial will be performed, in which erythematous lupus patients will complete a placebo supplementation.The placebo and vitamin B12 + folic acid supplement will be indistinguishable in terms of taste, smell, and appearance.

Primary outcomes

  1. Change from baseline on DNA methylation profile at 12 weeks

    Time frame: Baseline and 12 weeks

    Percentage of DNA methylation level

  2. Change from baseline on weight at 12 weeks

    Time frame: Baseline and 12 weeks

    Weight in kilograms

  3. Change from baseline on serum vitamin B12 concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum vitamin B12 concentrations in pg/mL

  4. Change from baseline on serum folic acid concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum folic acid concentrations in ng/mL

Secondary outcomes

  1. Age of onset

    Time frame: Baseline

    Units of Measure: years

  2. Duration of disease since diagnosis

    Time frame: Baseline

    Units of Measure: years

  3. Change from baseline on miR-146 expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative miR-146 expression

  4. Change from baseline on miR-181 expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative miR-181 expression

  5. Change from baseline on miR-21 expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative miR-21 expression

  6. Change from baseline on miR-126 expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative miR-126 expression

  7. Change from baseline on TNF-a gene expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative gene expression of TNF-a

  8. Change from baseline on LEP gene expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative gene expression of LEP

  9. Change from baseline on ADIPOQ gene expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative gene expression of ADIPOQ

  10. Change from baseline on MTHFR gene expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative gene expression of MTHFR

  11. Change from baseline on STAT3 gene expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative gene expression of STAT3

  12. Change from baseline on IL-6 gene expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative gene expression of IL-6

  13. Change from baseline on DNMT1 gene expression at 12 weeks

    Time frame: Baseline and 12 weeks

    Relative gene expression of DNMT1

  14. Change from baseline on serum leptin concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum leptin concentration in ng/mL

  15. Change from baseline on serum IL-6 concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum IL-6 concentration in ng/mL

  16. Change from baseline on serum IL-17 concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum IL-17 concentration in ng/mL

  17. Change from baseline on serum IL-2 concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum IL-2 concentration in ng/mL

  18. Change from baseline on serum TNF-a concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum TNF-a concentration in ng/mL

  19. Change from baseline on serum C-reactive protein concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum C-reactive protein concentration in ng/mL

  20. Change from baseline on serum adipokines concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum adipokines concentration in ng/mL

  21. Change from baseline on serum triglycerides concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum triglycerides concentration in mg/dL

  22. Change from baseline on serum cholesterol concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum cholesterol concentrations in mg/dL

  23. Change from baseline on serum glucose concentrations at 12 weeks

    Time frame: Baseline and 12 weeks

    Serum glucose concentrations in mg/dL

  24. Change from baseline on dietary intake at 12 weeks

    Time frame: Baseline and 12 weeks

    Dietary intake in g and percentage

  25. Change from baseline on abdominal circumference at 12 weeks

    Time frame: Baseline and 12 weeks

    Abdominal circumference in centimeters

  26. Change from baseline on fat mass at 12 weeks

    Time frame: Baseline and 12 weeks

    Fat mass in kilograms

  27. Change from baseline on fat free mass at 12 weeks

    Time frame: Baseline and 12 weeks

    Fat free mass in kilograms

  28. Change from baseline on body mass index at 12 weeks

    Time frame: Baseline and 12 weeks

    Body mass index in kilograms/meters^2

  29. Change from baseline on height at 12 weeks

    Time frame: Baseline and 12 weeks

    Height in meters

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effect of Methyl-donor Nutrient Supplementation on Methylation Profile of Inflammatory-related Genes in Lupus Patients With Obesity: a Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2026
First posted
Oct 28, 2021
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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