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The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)

NCT ID: NCT01425775

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-05-31

Brief Summary

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Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease. Vitamin D has potent immunomodulatory properties that have promoted its potential use in the treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE patients and determined alterations in inflammatory, hemostatic markers as well as disease activity before and after vitamin D supplementation.

248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months. Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18, TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12 months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were classified as vitamin D insufficiency, and levels \< 10 ng/ml as vitamin D deficiency.The mean 25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Keywords

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SLE disease activity markers vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

Group Type ACTIVE_COMPARATOR

vitamin D 25(OH)D

Intervention Type DRUG

2000IU/day for 12 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2000IU/day of vitamin D will be compared to similar looking tablets of placebo for 12 months

Interventions

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vitamin D 25(OH)D

2000IU/day for 12 months

Intervention Type DRUG

Placebo

2000IU/day of vitamin D will be compared to similar looking tablets of placebo for 12 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Premenopausal women and males of the same body mass index and ethnicity

Exclusion Criteria

Patients with:

* other inflammatory disorders,
* hepatic disease
* renal disease
* malignant disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Anna Abou-Raya

Professor of Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Abou-Raya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

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Faculty of Medicine, University of Alexandria

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Abou-Raya A, Abou-Raya S, Helmii M. The effect of vitamin D supplementation on inflammatory and hemostatic markers and disease activity in patients with systemic lupus erythematosus: a randomized placebo-controlled trial. J Rheumatol. 2013 Mar;40(3):265-72. doi: 10.3899/jrheum.111594. Epub 2012 Dec 1.

Reference Type DERIVED
PMID: 23204220 (View on PubMed)

Other Identifiers

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alexmed116618166

Identifier Type: -

Identifier Source: org_study_id