NCT01892748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

June 17, 2013

Last Update Submit

May 10, 2016

Conditions

Systemic Lupus Erythematosus

Keywords

LupusJuvenileCholecalciferolDisease activityBone MassFatigueSafety

Outcome Measures

Primary Outcomes (1)

  • The change in Disease Activity Score (SLEDAI)

    baseline to week 12 and 24

Secondary Outcomes (2)

  • The change in Fatigue Score

    baseline to week 12 and 24

  • The change in Bone Mineral Parameters

    baseline to week 12 and 24

Study Arms (2)

Cholecalciferol 50.000IU/week

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

patients receive placebo in similar capsules of cholecalciferol for 24weeks

Drug: Placebo

Interventions

CholecalciferolDRUG

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.

Also known as: Vitamin D3
Cholecalciferol 50.000IU/week
PlaceboDRUG

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.

Also known as: No other names
Placebo

Eligibility Criteria

Age10 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Written informed consent signed
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo - School of Medicine

São Paulo, São Paulo, 01246-903, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 29152675DERIVED

  • 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.

    PMID: 25988278DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicFatigue

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Rosa MR Pereira, MD PhD

    University of Sao Paulo - School of Medicine

    PRINCIPAL INVESTIGATOR

  • Glauce L Lima, MD

    University of Sao Paulo - School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2013

First Posted

July 4, 2013

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

February 1, 2014

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

BR(1)