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Vitamin D Regulates the Expression of Glucocorticoid Receptors in Blood of Severe Asthmatic Patients (VitaminD)

Primary Purpose

Effect of Drug

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Dubai Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Effect of Drug

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of asthma
  • age group between 18 and 65 years
  • low level of 25-hydroxyvitamin D3 (25 D3) level less than 20ng/mL

Exclusion Criteria:

  • smoker patients
  • less than 18 years old
  • patient on Vitamin D supplementation already

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Asthmatic low vitamin D on treatment

    Asthmatic low vitamin D on placepo

    Arm Description

    asthmatic patient low vitamin D level received treatment for Vitamin D 50000IU weekly

    asthmatic patient low vitamin D level received placepo

    Outcomes

    Primary Outcome Measures

    The top Vitamin D regulated pathways in response to Steroids by using Comparative Toxicogenomics Database from thousands of experiments.
    identify VitD targeted enriched pathways, we analyzed Comparative Toxicogenomics .Enriched Ontology Clustering for the identified genes was performed using the Metascape (a web-based tool used for comprehensive gene list annotation and analysis resource)Database from thousands of experiments.
    Asthma Severity effects on VDR and steroid receptors genes by inalyzing expression profile of publicly available datasets (GSE69683) which has a large number of participants and detailed clinical information.
    analyze the expression profile of publicly available datasets (GSE69683) which has a large number of participants and detailed clinical information.
    Examine the up-regulation of GR-α receptor by using supplementation of vitamin D on 45 vitamin D deficient asthmatics
    by doing double-blinded, randomized, placebo-controlled study was performed to test the effect of VitD supplementation on 45 vitamin D deficient asthmatics.Standard statistical t-tests and one-way ANOVA were performed to test for statistical significance between data groups using GraphPad Prism 8 (GraphPad, San Diego, CA, USA). p < 0.05 was considered significant.
    Effects of IL-17 and IL-4 cytokines in asthmatic patients while using Vitamin D supplementation by using ELISA assay
    by doing double-blinded, randomized, placebo-controlled study was performed to test the effect of VitD supplementation on 45 vitamin D deficient asthmatics. Using qRT-PCR expression of the cytokines
    Effects of IL-17 and IL-4 cytokines in asthmatic patients while using Vitamin D supplementation by using ELISA assay
    by doing double-blinded, randomized, placebo-controlled study was performed to test the effect of VitD supplementation on 45 vitamin D deficient asthmatics.using Bioplex multiplex immunoassay (BioRad, CA,USA) was used to assess the protein expression of the cytokines and by measuring fold change.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2020
    Last Updated
    June 19, 2020
    Sponsor
    Dubai Health Authority
    Collaborators
    McGill University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04443387
    Brief Title
    Vitamin D Regulates the Expression of Glucocorticoid Receptors in Blood of Severe Asthmatic Patients
    Acronym
    VitaminD
    Official Title
    Vitamin D Regulates the Expression of Glucocorticoid Receptors in Blood of Severe Asthmatic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2012 (Actual)
    Primary Completion Date
    April 30, 2014 (Actual)
    Study Completion Date
    December 31, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dubai Health Authority
    Collaborators
    McGill University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Vitamin D (VitD) deficiency is a significant public health concern in many areas around the globe which has been associated with many immune-mediated diseases, including asthma. Severe asthma has been linked with a decreased glucocorticoid receptors (GR) ratio (GR-α/ GR-β ratio), indicating steroid hyporesponsiveness. Using combined in silico and in vivo approaches, aimed to explore the immunomodulatory effect of VitD on asthmatic patients diagnosed with hypovitaminosis D.
    Detailed Description
    Vitamin D (VitD) deficiency is a significant public health concern in many areas around the globe which has been associated with many immune-mediated diseases, including asthma. Severe asthma has been linked with a decreased glucocorticoid receptors (GR) ratio (GR-α/ GR-β ratio), indicating steroid hyporesponsiveness. Using combined in silico and in vivo approaches, the investigators aimed to explore the immunomodulatory effect of VitD on asthmatic patients diagnosed with hypovitaminosis D. Methods: In silico tools were used to identify the regulatory effect of VitD supplementation on GR genes. The investigators measured the expression levels of GR-α and the inactive isoform, GR-β, in the blood of adult asthmatics diagnosed with hypovitaminosis D before and after VitD supplementation. Moreover, the blood levels of inflammatory cytokines associated with asthma severity were determined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Effect of Drug

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    double blinded randomized study
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Asthmatic low vitamin D on treatment
    Arm Type
    Active Comparator
    Arm Description
    asthmatic patient low vitamin D level received treatment for Vitamin D 50000IU weekly
    Arm Title
    Asthmatic low vitamin D on placepo
    Arm Type
    Placebo Comparator
    Arm Description
    asthmatic patient low vitamin D level received placepo
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin D
    Intervention Description
    A double-blinded, randomized, placebo-controlled study of VitD supplementation on 45 asthmatics with VitD deficiency was performed. Moderate to severe asthmatics between 18 and 65 years of age who had clinician-diagnosed asthma with 25-hydroxyvitamin D3 (25 D3) level less than 20ng/mL at the screening visit were recruited at the Rashid Hospital, Dubai, U.A.E., and the Zayed Military Hospital, Abu Dhabi, U.A.E. Subjects were excluded if they had used any previous VitD supplementation, had any other respiratory diseases or co-morbid conditions or were smokers. According to the American Academy of Family Physicians guidelines, participants received 50, 000 IU of VitD orally or placebo weekly over 8 weeks. Subjects were blinded to treatment and allocated to receive a VitD dose or placebo by the randomization schedule.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    A double-blinded, randomized, placebo-controlled study of VitD supplementation on 45 asthmatics with VitD deficiency was performed. Moderate to severe asthmatics between 18 and 65 years of age who had clinician-diagnosed asthma with 25-hydroxyvitamin D3 (25 D3) level less than 20ng/mL at the screening visit were recruited at the Rashid Hospital, Dubai, U.A.E., and the Zayed Military Hospital, Abu Dhabi, U.A.E. Subjects were excluded if they had used any previous VitD supplementation, had any other respiratory diseases or co-morbid conditions or were smokers. According to the American Academy of Family Physicians guidelines, participants received 50, 000 IU of VitD orally or placebo weekly over 8 weeks. Subjects were blinded to treatment and allocated to receive a VitD dose or placebo by the randomization schedule.
    Primary Outcome Measure Information:
    Title
    The top Vitamin D regulated pathways in response to Steroids by using Comparative Toxicogenomics Database from thousands of experiments.
    Description
    identify VitD targeted enriched pathways, we analyzed Comparative Toxicogenomics .Enriched Ontology Clustering for the identified genes was performed using the Metascape (a web-based tool used for comprehensive gene list annotation and analysis resource)Database from thousands of experiments.
    Time Frame
    8 weeks
    Title
    Asthma Severity effects on VDR and steroid receptors genes by inalyzing expression profile of publicly available datasets (GSE69683) which has a large number of participants and detailed clinical information.
    Description
    analyze the expression profile of publicly available datasets (GSE69683) which has a large number of participants and detailed clinical information.
    Time Frame
    8 weeks
    Title
    Examine the up-regulation of GR-α receptor by using supplementation of vitamin D on 45 vitamin D deficient asthmatics
    Description
    by doing double-blinded, randomized, placebo-controlled study was performed to test the effect of VitD supplementation on 45 vitamin D deficient asthmatics.Standard statistical t-tests and one-way ANOVA were performed to test for statistical significance between data groups using GraphPad Prism 8 (GraphPad, San Diego, CA, USA). p < 0.05 was considered significant.
    Time Frame
    8 weeks
    Title
    Effects of IL-17 and IL-4 cytokines in asthmatic patients while using Vitamin D supplementation by using ELISA assay
    Description
    by doing double-blinded, randomized, placebo-controlled study was performed to test the effect of VitD supplementation on 45 vitamin D deficient asthmatics. Using qRT-PCR expression of the cytokines
    Time Frame
    8 weeks
    Title
    Effects of IL-17 and IL-4 cytokines in asthmatic patients while using Vitamin D supplementation by using ELISA assay
    Description
    by doing double-blinded, randomized, placebo-controlled study was performed to test the effect of VitD supplementation on 45 vitamin D deficient asthmatics.using Bioplex multiplex immunoassay (BioRad, CA,USA) was used to assess the protein expression of the cytokines and by measuring fold change.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of asthma age group between 18 and 65 years low level of 25-hydroxyvitamin D3 (25 D3) level less than 20ng/mL Exclusion Criteria: smoker patients less than 18 years old patient on Vitamin D supplementation already

    12. IPD Sharing Statement

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    Vitamin D Regulates the Expression of Glucocorticoid Receptors in Blood of Severe Asthmatic Patients

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