Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.

R

ROSA MARIA RODRIGUES PEREIRA

Status

Completed

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Placebo
Drug: Cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT01892748
VITD59/11

Details and patient eligibility

About

The potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients, especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE). The objective of this study is to evaluate the effect of vitamin D supplementation (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity (clinical and laboratory parameters), fatigue and bone mass.

Full description

This is a study 24-week, two arm, double blinded randomized clinical trial to evaluate the effects of high-dose vitamin D3 supplementation compared with placebo, on activity disease, fatigue and bone mass. Sixty JoSLE patients will be randomized to receive placebo or vitamin D3 (50.000 IU/week) for 24weeks. The patients return to visits in week 12 and week 24 for evaluation. Study will record clinical history, drugs in use, disease activity, and bone mass parameters.

Enrollment

60 patients

Sex

Female

Ages

10 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Written informed consent signed * 4 of the 11 modified American College of Rheumatology (ACR) Revised Criteria for the Classification of Systemic Lupus Erythematosus . * SLEDAI \< 8 at Screening and at Baseline * Stable immunosuppressive dose prior to randomization. * Body Mass Index \< 30 * Able to swallow pills at randomization

Exclusion criteria

* Refuse of the patient or the legal responsible * Use of vitamin D2 or D3 supplementation * Significant renal insufficiency * Primary hyperparathyroidism (known) * History of nephrolithiasis (known) * Diabetes mellitus requiring insulin therapy * History of vertebral compression fractures (known) * Pregnancy * Use of bisphosphonates

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Cholecalciferol 50.000IU/week
Active Comparator group
Description:
patients will receive vitamin D3 (50.000 IU/week) for 24weeks
Treatment:
Drug: Cholecalciferol
Placebo
Placebo Comparator group
Description:
patients receive placebo in similar capsules of cholecalciferol for 24weeks
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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