Vitamin D as a Key Player in Rheumatoid Arthritis

NCT ID: NCT04344405

Last Updated: 2021-06-24

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

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-06-01

Brief Summary

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Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation and group II will receive placebo and follow up for 3 months.

Detailed Description

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Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation and group II will receive placebo and follow up for 3 months.

Conditions

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the Immunomodulatory Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vit D

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

vitamin D supplementation

control

Group Type ACTIVE_COMPARATOR

Steroid Drug

Intervention Type DRUG

control

Interventions

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Vitamin D

vitamin D supplementation

Intervention Type DRUG

Steroid Drug

control

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* RA patients

Exclusion Criteria

* Patients with inflammatory bowel disease patients with any other autoimmune diseases
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Manal Hassanien

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Manal Hassanien

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Vit D in RA

Identifier Type: -

Identifier Source: org_study_id

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