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Completed

NCT Number: NCT02993302

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

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.

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Key information

Conditions

Graves Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1α-D3

Drug

patients were given PTU and 1α-D3

Other names: 1α 25-dihydroxyvitamin d3, alfacalcidol

Placebos

Drug

patients were given PTU and placebos

Other names: placebo

Primary outcomes

  1. CD80 Level

    Time frame: 1 year

    Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)

  2. CD206 Level

    Time frame: 1 year

    Dendritic cells maturation levels were measured by the CD206

  3. IL-12/IL-10 Ratio

    Time frame: 1 year

    Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio

  4. fT4 Levels

    Time frame: 1 year

    fT4 (free thyroxine)

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Collaborators

  • Indonesia University

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 15, 2016
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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