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
About this trial
This is an interventional treatment trial for Graves Disease focused on measuring vitamin D, graves' disease, dendritic cells
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
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
NCT ID
NCT02993302
First Posted
December 7, 2016
Last Updated
February 21, 2020
Sponsor
Dr Cipto Mangunkusumo General Hospital
Collaborators
Indonesia University
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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