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High versus low dose Vitamin D3 in severe Systemic Lupus Erythematosus on Pulse Methylprednisolone: a randomized, double blind, placebo controlled clinical trial

Assessment of Vitamin D supplementation in patients with Systemic Lupus Erythematosus admitted to the rheumatology ward

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10t8m6m2
Enrollment
Unknown
Registered
2025-02-12
Start date
2015-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D, glucocorticoids

Interventions

This was a two-arm, double-blind, randomized controlled clinical trial conducted between May 2015 and November 2019. Forty patients with Systemic Lupus Erythematosus were consecutively selected and we
D04.210.500.247.222.159

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with Systemic Lupus Erythematosus (according to the classification criteria defined by the Systemic Lupus International Collaborating Clinics of 2012). Age greater than or equal to 18 years. High disease activity (SLEDAI-2K greater than 11) requiring hospitalization for administration of intravenous pulse therapy with methylprednisolone. Patients with Systemic Lupus Erythematosus and concomitant infection were also eligible, provided they presented active disease after clinical evaluation. Both sexes

Exclusion criteria

Exclusion criteria: Concomitant diagnosis of another autoimmune disease; Body Mass Index - BMI greater than or equal to 35 kg/m2; severe renal failure - estimated glomerular filtration rate below 30 ml/min; history of nephrolithiasis, hypercalciuria (greater than or equal to 4 mg/kg/24 hours); hypercalcemia (total calcium corrected by albumin greater than 10.2 mg/dl); intestinal malabsorption; chronic liver disease; pregnancy, lactation; refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
It is expected to find an improvement in disease activity markers in patients with high-activity Systemic Lupus Erythematosus after vitamin D3 supplementation; regardless of concomitant immunosuppressive treatment and specific vitamin D dose regimen;To demonstrate that high doses of vitamin D3 represent an effective and safe supplementation strategy in patients with Systemic Lupus Erythematosus treated with high doses of glucocorticoids—

Secondary

MeasureTime frame
No secondary outcomes are expected—

Countries

Brazil

Contacts

Public ContactDiogo Domiciano

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

dsdomiciano@hotmail.com+55-11-3061-7490

Outcome results

None listed

Source: REBEC (via WHO ICTRP)