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OpenTrials
Completed

NCT Number: NCT01892748

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Fatigue Immune System Diseases Lupus Erythematosus, Systemic Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

10 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo - School of Medicine

São Paulo, 01246-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

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.

Other names: Vitamin D3

Placebo

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.

Other names: No other names

Primary outcomes

  1. The change in Disease Activity Score (SLEDAI)

    Time frame: baseline to week 12 and 24

Secondary outcomes

  1. The change in Fatigue Score

    Time frame: baseline to week 12 and 24

  2. The change in Bone Mineral Parameters

    Time frame: baseline to week 12 and 24

Sponsors and collaborators

Lead sponsor

ROSA MARIA RODRIGUES PEREIRA

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jul 4, 2013
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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