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AzTrials

Graves DiseasePhase 2NCT02993302

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

A Phase 2 study testing 1α-D3 in people with Graves Disease, run by Dr Cipto Mangunkusumo General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Graves Disease
What is being tested?
1α-D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
No sites listed yet
Study dates
Jul 2014to Mar 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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.

Read the 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.

Conditions
Graves Disease
Being tested
1α-D3, Placebos
Keywords
vitamin D, graves' disease, dendritic cells
Medical subject headings
Graves Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1α-D3Drug

    Also called 1α 25-dihydroxyvitamin d3, alfacalcidol

    patients were given PTU and 1α-D3

  • PlacebosDrug

    Also called placebo

    patients were given PTU and placebos

Study groups in NCT02993302
Study groupRoleWhat they receive
PTU-Oral 1α-D3Active comparatorpatients 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
Receives: Drug: 1α-D3
PTU-PlacebosPlacebo comparatorpatients 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
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CD80 Level

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

    Measured: 1 year

  2. CD206 Level

    Dendritic cells maturation levels were measured by the CD206

    Measured: 1 year

  3. IL-12/IL-10 Ratio

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

    Measured: 1 year

  4. fT4 Levels

    fT4 (free thyroxine)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2016 (estimated)
  2. Study startJul 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02993302
Sponsor's protocol ID
RSCM/FKUI
Status last verified
Feb 2020
First submitted
7 Dec 2016
Last updated
4 Mar 2020
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Tamura M, Matsuura B, Miyauchi S, Onji M. Dendritic cells produce interleukin-12 in hyperthyroid mice. Eur J Endocrinol. 1999 Dec;141(6):625-9. doi: 10.1530/eje.0.1410625.

    PubMed 10601966

  • Banchereau J, Steinman RM. Dendritic cells and the control of immunity. Nature. 1998 Mar 19;392(6673):245-52. doi: 10.1038/32588.

    PubMed 9521319

  • Liang S, Ristich V, Arase H, Dausset J, Carosella ED, Horuzsko A. Modulation of dendritic cell differentiation by HLA-G and ILT4 requires the IL-6--STAT3 signaling pathway. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8357-62. doi: 10.1073/pnas.0803341105. Epub 2008 Jun 11.

    PubMed 18550825

  • Inoue N, Watanabe M, Morita M, Tatusmi K, Hidaka Y, Akamizu T, Iwatani Y. Association of functional polymorphisms in promoter regions of IL5, IL6 and IL13 genes with development and prognosis of autoimmune thyroid diseases. Clin Exp Immunol. 2011 Mar;163(3):318-23. doi: 10.1111/j.1365-2249.2010.04306.x. Epub 2011 Jan 14.

    PubMed 21235536

  • Khalilzadeh O, Anvari M, Esteghamati A, Momen-Heravi F, Mahmoudi M, Rashidi A, Amiri HM, Ranjbar M, Tabataba-Vakili S, Amirzargar A. The interleukin-1 family gene polymorphisms and Graves' disease. Ann Endocrinol (Paris). 2010 Sep;71(4):281-5. doi: 10.1016/j.ando.2010.01.005. Epub 2010 Apr 18.

    PubMed 20400062

  • Croizet K, Rabilloud R, Kostrouch Z, Nicolas JF, Rousset B. Culture of dendritic cells from a nonlymphoid organ, the thyroid gland: evidence for TNFalpha-dependent phenotypic changes of thyroid-derived dendritic cells. Lab Invest. 2000 Aug;80(8):1215-25. doi: 10.1038/labinvest.3780129.

    PubMed 10950112

  • Dedecjus M, Stasiolek M, Brzezinski J, Selmaj K, Lewinski A. Thyroid hormones influence human dendritic cells' phenotype, function, and subsets distribution. Thyroid. 2011 May;21(5):533-40. doi: 10.1089/thy.2010.0183. Epub 2010 Dec 29.

    PubMed 21190445

  • Hughes GC, Clark EA. Regulation of dendritic cells by female sex steroids: relevance to immunity and autoimmunity. Autoimmunity. 2007 Sep;40(6):470-81. doi: 10.1080/08916930701464764.

    PubMed 17729041

  • Duperrier K, Farre A, Bienvenu J, Bleyzac N, Bernaud J, Gebuhrer L, Rigal D, Eljaafari A. Cyclosporin A inhibits dendritic cell maturation promoted by TNF-alpha or LPS but not by double-stranded RNA or CD40L. J Leukoc Biol. 2002 Nov;72(5):953-61.

    PubMed 12429717

  • Berer A, Stockl J, Majdic O, Wagner T, Kollars M, Lechner K, Geissler K, Oehler L. 1,25-Dihydroxyvitamin D(3) inhibits dendritic cell differentiation and maturation in vitro. Exp Hematol. 2000 May;28(5):575-83. doi: 10.1016/s0301-472x(00)00143-0.

    PubMed 10812248

  • Wahono CS, Rusmini H, Soelistyoningsih D, Hakim R, Handono K, Endharti AT, Kalim H, Widjajanto E. Effects of 1,25(OH)2D3 in immune response regulation of systemic lupus erithematosus (SLE) patient with hypovitamin D. Int J Clin Exp Med. 2014 Jan 15;7(1):22-31. eCollection 2014.

    PubMed 24482685

  • Bartels LE, Jorgensen SP, Bendix M, Hvas CL, Agnholt J, Agger R, Dahlerup JF. 25-Hydroxy vitamin D3 modulates dendritic cell phenotype and function in Crohn's disease. Inflammopharmacology. 2013 Apr;21(2):177-86. doi: 10.1007/s10787-012-0168-y. Epub 2013 Jan 23.

    PubMed 23341164

  • Agmon-Levin N, Theodor E, Segal RM, Shoenfeld Y. Vitamin D in systemic and organ-specific autoimmune diseases. Clin Rev Allergy Immunol. 2013 Oct;45(2):256-66. doi: 10.1007/s12016-012-8342-y.

    PubMed 23238772

  • Zhou H, Xu C, Gu M. Vitamin D receptor (VDR) gene polymorphisms and Graves' disease: a meta-analysis. Clin Endocrinol (Oxf). 2009 Jun;70(6):938-45. doi: 10.1111/j.1365-2265.2008.03413.x. Epub 2008 Sep 8.

    PubMed 18782354

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1α-D3 in people with Graves Disease, run by Dr Cipto Mangunkusumo General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD80 Level (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02993302, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.

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