Graves Disease
Conditions
Keywords
vitamin D, graves' disease, dendritic cells
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.
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.
Interventions
DRUG1α-D3
patients were given PTU and 1α-D3
DRUGPlacebos
patients were given PTU and placebos
Sponsors
Indonesia University
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD80 Level | 1 year | Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80) |
| CD206 Level | 1 year | Dendritic cells maturation levels were measured by the CD206 |
| IL-12/IL-10 Ratio | 1 year | Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio |
| fT4 Levels | 1 year | fT4 (free thyroxine) |
Participant flow
Recruitment details
May 2014 - May 2015, Patients with Graves' disease who are still in hyperthyroid condition at the outpatient clinic of Endocrinology Department of Dr. Cipto Mangunkusumo Hospital in Jakarta, Indonesia.
Participants by arm
| Arm | Count |
|---|---|
| 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
1α-D3: patients were given PTU and 1α-D3 | 13 |
| 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
Placebos: patients were given PTU and placebos | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Total | PTU + Oral 1α-D3 | PTU + Placebos |
|---|---|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 8.81 | 33.67 years STANDARD_DEVIATION 7.92 | 38.15 years STANDARD_DEVIATION 9.34 |
| Ca ion levels | 1.13 mmol/L STANDARD_DEVIATION 0.05 | 1.13 mmol/L STANDARD_DEVIATION 0.05 | 1.13 mmol/L STANDARD_DEVIATION 0.06 |
| Duration of illness | 24 months | 18 months | 27 months |
| free thyroxine (fT4) levels | 5.04 ng/dL | 6.9 ng/dL | 4.2 ng/dL |
| Sex: Female, Male Female | 23 Participants | 11 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
| thyroid-stimulating hormone (TSH) levels | 0.01 µIU/l | 0.01 µIU/l | 0.01 µIU/l |
| TSH receptor antibody (TRAb) levels | 14.174 U/L | 14.46 U/L | 9.55 U/L |
| Vitamin 25-D3 levels | 25 ng/mL STANDARD_DEVIATION 6.62 | 24.4 ng/mL STANDARD_DEVIATION 7.81 | 25.55 ng/mL STANDARD_DEVIATION 5.56 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
CD206 Level
Dendritic cells maturation levels were measured by the CD206
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTU + Oral 1α-D3 | CD206 Level | 54.08 nM | Standard Deviation 23.46 |
| PTU + Placebos | CD206 Level | 53.42 nM | Standard Deviation 13.72 |
p-value: 0.47Wilcoxon (Mann-Whitney)
Primary
CD80 Level
Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PTU + Oral 1α-D3 | CD80 Level | 45.60 nM |
| PTU + Placebos | CD80 Level | 54.51 nM |
p-value: 0.48Wilcoxon (Mann-Whitney)
Primary
fT4 Levels
fT4 (free thyroxine)
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTU + Oral 1α-D3 | fT4 Levels | 2.65 ng/dL | Standard Deviation 2.06 |
| PTU + Placebos | fT4 Levels | 2.09 ng/dL | Standard Deviation 1.19 |
Primary
IL-12/IL-10 Ratio
Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PTU + Oral 1α-D3 | IL-12/IL-10 Ratio | 0.49 ratio |
| PTU + Placebos | IL-12/IL-10 Ratio | 0.21 ratio |
p-value: 0.53Wilcoxon (Mann-Whitney)