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

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12) for lupus (sle).

It had four arms (groups): Supplemented Normal Weight Group (experimental), Supplemented Excess Body Weight Group (experimental), Control Normal Weight Group (placebo comparator) and Control Excess Body Weight Group (placebo comparator).

Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive supplementation.

Patients with excess body weight (BMI \> 25 kg/m²) that will receive supplementation.

Patients with normal weight (BMI between 18.5 and 24.9 kg/m²) that will receive placebo.

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 51 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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). BMI \> 18,5 kg/m2.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: current infection; arterial hypertension; anticoagulants use.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The lupus (sle) participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2022-01-01 with completion listed for 2022-07-31.

It ran at 1 site in Brazil.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change from baseline on DNA methylation profile at 12 weeks (time frame: Baseline and 12 weeks). Change from baseline on weight at 12 weeks (time frame: Baseline and 12 weeks). Change from baseline on serum vitamin B12 concentrations at 12 weeks (time frame: Baseline and 12 weeks).

It also tracked 29 secondary outcomes, for example Age of onset, Duration of disease since diagnosis, Change from baseline on miR-146 expression at 12 weeks, Change from baseline on miR-181 expression at 12 weeks, Change from baseline on miR-21 expression at 12 weeks and Change from baseline on miR-126 expression at 12 weeks.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 51 people with lupus (sle).

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Lupus (SLE) research.