Trial Outcomes & Findings for Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder (NCT NCT01633853)
NCT ID: NCT01633853
Last Updated: 2016-02-15
Results Overview
The blood levels of calcium at the 24th month of following up will be detected.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
204 participants
Primary outcome timeframe
24 months
Results posted on
2016-02-15
Participant Flow
Participant milestones
| Measure |
Vitamin D2
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
100
|
|
Overall Study
COMPLETED
|
104
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
Baseline characteristics by cohort
| Measure |
Vitamin D2
n=104 Participants
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
n=100 Participants
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.35 years
STANDARD_DEVIATION 5.64 • n=99 Participants
|
56.27 years
STANDARD_DEVIATION 5.94 • n=107 Participants
|
56.89 years
STANDARD_DEVIATION 6.76 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
104 participants
n=99 Participants
|
100 participants
n=107 Participants
|
204 participants
n=206 Participants
|
|
Ca-baseline
|
2.29 mmol/L
STANDARD_DEVIATION 0.14 • n=99 Participants
|
2.31 mmol/L
STANDARD_DEVIATION 0.11 • n=107 Participants
|
2.30 mmol/L
STANDARD_DEVIATION 0.12 • n=206 Participants
|
|
P-baseline
|
1.15 mmol/L
STANDARD_DEVIATION 0.24 • n=99 Participants
|
1.14 mmol/L
STANDARD_DEVIATION 0.21 • n=107 Participants
|
1.14 mmol/L
STANDARD_DEVIATION 0.22 • n=206 Participants
|
|
iPTH-baseline
|
109.7 ng/ml
STANDARD_DEVIATION 127.8 • n=99 Participants
|
89.5 ng/ml
STANDARD_DEVIATION 75.0 • n=107 Participants
|
98.2 ng/ml
STANDARD_DEVIATION 100.1 • n=206 Participants
|
|
25(OH)Vit D
|
15.14 ng/ml
STANDARD_DEVIATION 7.46 • n=99 Participants
|
14.90 ng/ml
STANDARD_DEVIATION 6.15 • n=107 Participants
|
15.02 ng/ml
STANDARD_DEVIATION 6.83 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe blood levels of calcium at the 24th month of following up will be detected.
Outcome measures
| Measure |
Vitamin D2
n=104 Participants
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
n=100 Participants
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
|---|---|---|
|
The Blood Levels of Calcium at the 24th Month of Following up.
|
2.31 mmol/L
Standard Deviation 0.14
|
2.33 mmol/L
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: 24 monthsThe blood levels of phosphorus at the 24th month of following up will be detected.
Outcome measures
| Measure |
Vitamin D2
n=104 Participants
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
n=100 Participants
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
|---|---|---|
|
The Blood Levels of Phosphorus at the 24th Month of Following up.
|
1.27 mmol/L
Standard Deviation 0.39
|
1.25 mmol/L
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: 24 monthsThe blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.
Outcome measures
| Measure |
Vitamin D2
n=104 Participants
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
n=100 Participants
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
|---|---|---|
|
The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
|
96.5 pg/ml
Standard Deviation 87.1
|
108.1 pg/ml
Standard Deviation 134.0
|
SECONDARY outcome
Timeframe: 24 monthsThe levels of blood 25(OH)Vitamin D at the 24th month of following up.
Outcome measures
| Measure |
Vitamin D2
n=104 Participants
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
n=100 Participants
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
|---|---|---|
|
The Blood 25(OH)Vitamin D Level.
|
37.31 ng/ml
Standard Deviation 10.49
|
18.07 ng/ml
Standard Deviation 7.55
|
SECONDARY outcome
Timeframe: 24 monthsPatients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups.
Outcome measures
| Measure |
Vitamin D2
n=104 Participants
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
n=100 Participants
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
|---|---|---|
|
The Incidence Rate of Secondary Hyperparathyroidism.
|
14 participants
|
15 participants
|
Adverse Events
Vitamin D2
Serious events: 13 serious events
Other events: 10 other events
Deaths: 0 deaths
1,25(OH)2 Vitamin D3
Serious events: 10 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin D2
n=104 participants at risk
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
n=100 participants at risk
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
|---|---|---|
|
Cardiac disorders
AMI
|
1.9%
2/104
|
3.0%
3/100
|
|
Cardiac disorders
congestive heart failure
|
0.96%
1/104
|
3.0%
3/100
|
|
Nervous system disorders
Stroke
|
2.9%
3/104
|
2.0%
2/100
|
|
General disorders
In patient
|
6.7%
7/104
|
2.0%
2/100
|
Other adverse events
| Measure |
Vitamin D2
n=104 participants at risk
Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
Vitamin D2: Treatment with Vit D2.
|
1,25(OH)2 Vitamin D3
n=100 participants at risk
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
|
|---|---|---|
|
Renal and urinary disorders
Renal replacement therapy
|
9.6%
10/104
|
8.0%
8/100
|
Additional Information
Dr. Zhang Dongliang
Peking University Internetional Hospital
Phone: +86-10-69006561
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place