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

NCT ID: NCT01892748

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-02-28

Brief Summary

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.

Detailed 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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cholecalciferol 50.000IU/week

patients will receive vitamin D3 (50.000 IU/week) for 24weeks

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

All patients and physicians were blinded to group assignment and treatment allocation. The first group received oral cholecalciferol of 50,000 IU/week and for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.

Placebo

patients receive placebo in similar capsules of cholecalciferol for 24weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The second group received identical placebo tablets for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.

Interventions

Cholecalciferol

All patients and physicians were blinded to group assignment and treatment allocation. The first group received oral cholecalciferol of 50,000 IU/week and for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.

Intervention Type: DRUG

Placebo

The second group received identical placebo tablets for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.

Intervention Type: DRUG

Other Intervention Names

Vitamin D3; No other names

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ROSA MARIA RODRIGUES PEREIRA

OTHER

Sponsor Role: lead

Responsible Party

ROSA MARIA RODRIGUES PEREIRA

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rosa MR Pereira, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo - School of Medicine

Glauce L Lima, MD

Role: STUDY_CHAIR

University of Sao Paulo - School of Medicine

Locations

University of Sao Paulo - School of Medicine

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Lima GL, Paupitz JA, Aikawa NE, Alvarenga JC, Pereira RMR. A randomized double-blind placebo-controlled trial of vitamin D supplementation in juvenile-onset systemic lupus erythematosus: positive effect on trabecular microarchitecture using HR-pQCT. Osteoporos Int. 2018 Mar;29(3):587-594. doi: 10.1007/s00198-017-4316-5. Epub 2017 Nov 19.

Reference Type: DERIVED

PMID: 29152675 (View on PubMed)

Lima GL, Paupitz J, Aikawa NE, Takayama L, Bonfa E, Pereira RM. Vitamin D Supplementation in Adolescents and Young Adults With Juvenile Systemic Lupus Erythematosus for Improvement in Disease Activity and Fatigue Scores: A Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Care Res (Hoboken). 2016 Jan;68(1):91-8. doi: 10.1002/acr.22621.

Reference Type: DERIVED

PMID: 25988278 (View on PubMed)

Other Identifiers

VITD59/11

Identifier Type: -

Identifier Source: org_study_id