Phase 2
N=25
Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
Graves Disease
Bottom Line
View on ClinicalTrials.gov: NCT02993302 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: CD80 Level — 45.60; 54.51 nM — p=0.48
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 1α-D3 (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CD80 Level |
45.60; 54.51 | 0.48 |
| PRIMARY CD206 Level |
54.08; 53.42 | 0.47 |
| PRIMARY IL-12/IL-10 Ratio |
0.49; 0.21 | 0.53 |
| PRIMARY fT4 Levels |
2.65; 2.09 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02993302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.