Trial Outcomes & Findings for Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients (NCT NCT02993302)
NCT ID: NCT02993302
Last Updated: 2020-03-04
Results Overview
Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
1 year
Results posted on
2020-03-04
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients
Baseline characteristics by cohort
| Measure |
PTU + Oral 1α-D3
n=13 Participants
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
|
PTU + Placebos
n=12 Participants
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
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.67 years
STANDARD_DEVIATION 7.92 • n=99 Participants
|
38.15 years
STANDARD_DEVIATION 9.34 • n=107 Participants
|
36 years
STANDARD_DEVIATION 8.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Duration of illness
|
18 months
n=99 Participants
|
27 months
n=107 Participants
|
24 months
n=206 Participants
|
|
thyroid-stimulating hormone (TSH) levels
|
0.01 µIU/l
n=99 Participants
|
0.01 µIU/l
n=107 Participants
|
0.01 µIU/l
n=206 Participants
|
|
free thyroxine (fT4) levels
|
6.9 ng/dL
n=99 Participants
|
4.2 ng/dL
n=107 Participants
|
5.04 ng/dL
n=206 Participants
|
|
TSH receptor antibody (TRAb) levels
|
14.46 U/L
n=99 Participants
|
9.55 U/L
n=107 Participants
|
14.174 U/L
n=206 Participants
|
|
Ca ion levels
|
1.13 mmol/L
STANDARD_DEVIATION 0.05 • n=99 Participants
|
1.13 mmol/L
STANDARD_DEVIATION 0.06 • n=107 Participants
|
1.13 mmol/L
STANDARD_DEVIATION 0.05 • n=206 Participants
|
|
Vitamin 25-D3 levels
|
24.4 ng/mL
STANDARD_DEVIATION 7.81 • n=99 Participants
|
25.55 ng/mL
STANDARD_DEVIATION 5.56 • n=107 Participants
|
25 ng/mL
STANDARD_DEVIATION 6.62 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearDendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
Outcome measures
| Measure |
PTU + Oral 1α-D3
n=13 Participants
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
|
PTU + Placebos
n=12 Participants
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
|
|---|---|---|
|
CD80 Level
|
45.60 nM
Interval 31.2 to 139.36
|
54.51 nM
Interval 39.47 to 69.55
|
PRIMARY outcome
Timeframe: 1 yearDendritic cells maturation levels were measured by the CD206
Outcome measures
| Measure |
PTU + Oral 1α-D3
n=13 Participants
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
|
PTU + Placebos
n=12 Participants
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
|
|---|---|---|
|
CD206 Level
|
54.08 nM
Standard Deviation 23.46
|
53.42 nM
Standard Deviation 13.72
|
PRIMARY outcome
Timeframe: 1 yearDendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio
Outcome measures
| Measure |
PTU + Oral 1α-D3
n=13 Participants
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
|
PTU + Placebos
n=12 Participants
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
|
|---|---|---|
|
IL-12/IL-10 Ratio
|
0.49 ratio
Interval 0.04 to 8.01
|
0.21 ratio
Interval 0.03 to 3.4
|
PRIMARY outcome
Timeframe: 1 yearfT4 (free thyroxine)
Outcome measures
| Measure |
PTU + Oral 1α-D3
n=13 Participants
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
|
PTU + Placebos
n=12 Participants
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
|
|---|---|---|
|
fT4 Levels
|
2.65 ng/dL
Standard Deviation 2.06
|
2.09 ng/dL
Standard Deviation 1.19
|
Adverse Events
PTU + Oral 1α-D3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PTU + Placebos
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place