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Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients

Primary Purpose

Graves Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
1α-D3
Placebos
Sponsored by
Dr Cipto Mangunkusumo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves Disease focused on measuring vitamin D, graves' disease, dendritic cells

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with Graves' disease and still have not gone into remission
  • Willing to participate in the research

Exclusion Criteria:

  • Pregnant patient
  • Suffered from severe liver disease
  • Suffered from severe kidney disease
  • Taking vitamin D substitution therapy
  • Suffered from another autoimmune disease
  • Suffered from malignancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    PTU-Oral 1α-D3

    PTU-Placebos

    Arm Description

    patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis

    patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis

    Outcomes

    Primary Outcome Measures

    CD80 Level
    Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
    CD206 Level
    Dendritic cells maturation levels were measured by the CD206
    IL-12/IL-10 Ratio
    Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio
    fT4 Levels
    fT4 (free thyroxine)

    Secondary Outcome Measures

    Full Information

    First Posted
    December 7, 2016
    Last Updated
    February 21, 2020
    Sponsor
    Dr Cipto Mangunkusumo General Hospital
    Collaborators
    Indonesia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02993302
    Brief Title
    Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
    Official Title
    Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr Cipto Mangunkusumo General Hospital
    Collaborators
    Indonesia University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro 1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral 1α-D3 on DC maturation in GD patients.
    Detailed Description
    Patients with Graves' disease were divided into two groups: groups receiving oral 1α-D3 in addition to propylthiouracil (PTU) and groups receiving placebos in addition to PTU. Comparison of DC maturation were performed before and after the oral 1α-D3. DC maturation was assessed based on the expression of DC markers (HLA-DR, CD80, CD40, CD83, CD14 and CD206) and the ratio of cytokines interleukin-12/IL-10.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Graves Disease
    Keywords
    vitamin D, graves' disease, dendritic cells

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PTU-Oral 1α-D3
    Arm Type
    Active Comparator
    Arm Description
    patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis
    Arm Title
    PTU-Placebos
    Arm Type
    Placebo Comparator
    Arm Description
    patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis
    Intervention Type
    Drug
    Intervention Name(s)
    1α-D3
    Other Intervention Name(s)
    1α 25-dihydroxyvitamin d3, alfacalcidol
    Intervention Description
    patients were given PTU and 1α-D3
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Other Intervention Name(s)
    placebo
    Intervention Description
    patients were given PTU and placebos
    Primary Outcome Measure Information:
    Title
    CD80 Level
    Description
    Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
    Time Frame
    1 year
    Title
    CD206 Level
    Description
    Dendritic cells maturation levels were measured by the CD206
    Time Frame
    1 year
    Title
    IL-12/IL-10 Ratio
    Description
    Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio
    Time Frame
    1 year
    Title
    fT4 Levels
    Description
    fT4 (free thyroxine)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with Graves' disease and still have not gone into remission Willing to participate in the research Exclusion Criteria: Pregnant patient Suffered from severe liver disease Suffered from severe kidney disease Taking vitamin D substitution therapy Suffered from another autoimmune disease Suffered from malignancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dyah Purnamasari, M.D., Ph.D
    Organizational Affiliation
    Fakultas Kedokteran Universitas Indonesia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients

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