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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02993302
Recruitment Status : Completed
First Posted : December 15, 2016
Results First Posted : February 20, 2020
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Indonesia University
Information provided by (Responsible Party):
Dyah Purnamasari, Dr Cipto Mangunkusumo General Hospital

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.

Condition or disease Intervention/treatment Phase
Graves Disease Drug: 1α-D3 Drug: Placebos Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
Study Start Date : July 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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 Name: placebo




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993302


Sponsors and Collaborators
Dr Cipto Mangunkusumo General Hospital
Indonesia University
Investigators
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Principal Investigator: Dyah Purnamasari, M.D., Ph.D Fakultas Kedokteran Universitas Indonesia
Publications of Results:
D Purnamasari PS, S Djauzi, S Setiati, A Harahap, J Prihartono. Effects of In Vitro 1,25 Dihydroxyvitamin D on Maturation of Dendritic Cells in Graves' Disease Patients. Asian J Pharm Clin Res. 2016; 9: 221-4
Handono K, Gani AA, Ekawati M and Wahono S. Serum level of vitamin D and autoantibodies level in systemic lupus erythematosus (SLE) patients. Journal of Pharmacy and Biological Sciences. 2012; 3: 16-20
D Purnamasari PS, S Djauzi. Sunlight-derived vitamin D affects interleukin-4 level, T helper 2 serum cytokines, in patients with Graves' disease: a prospective cohort study. Med J Indones. 2015; 24: 228-33

Other Publications:
Budiyati AD, Setiyono A, Tarigan E and Wibowo H. The effect of alpha fetoprotein on NF-kB translocation in lipopolysaccharide induced monocyte-derived dendritic cell. Med J Indones. 2012; 21.

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Responsible Party: Dyah Purnamasari, M.D., Ph.D, Dr Cipto Mangunkusumo General Hospital
ClinicalTrials.gov Identifier: NCT02993302    
Other Study ID Numbers: RSCM/FKUI
First Posted: December 15, 2016    Key Record Dates
Results First Posted: February 20, 2020
Last Update Posted: March 4, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dyah Purnamasari, Dr Cipto Mangunkusumo General Hospital:
vitamin D
graves' disease
dendritic cells
Additional relevant MeSH terms:
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Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Alfacalcidol
Dihydroxycholecalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances