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

February 21, 2020 updated by: Dyah Purnamasari, Dr Cipto Mangunkusumo General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: PTU-Oral 1α-D3
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
Drug: 1α-D3
patients were given PTU and 1α-D3
Other Names:
  • 1α 25-dihydroxyvitamin d3
  • alfacalcidol
PLACEBO_COMPARATOR: PTU-Placebos
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
Drug: Placebos
patients were given PTU and placebos
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD80 Level
Time Frame: 1 year
Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
1 year
CD206 Level
Time Frame: 1 year
Dendritic cells maturation levels were measured by the CD206
1 year
IL-12/IL-10 Ratio
Time Frame: 1 year
Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio
1 year
fT4 Levels
Time Frame: 1 year
fT4 (free thyroxine)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Cipto Mangunkusumo General Hospital

Collaborators

Indonesia University

Investigators

  • Principal Investigator: Dyah Purnamasari, M.D., Ph.D, Fakultas Kedokteran Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (ESTIMATE)

December 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSCM/FKUI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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