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CompletedNCT01633853Updated Feb 15, 2016Results posted

Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder

A Phase 4 interventional study of Vitamin D2 and 1,25(OH)2 Vit D3 in Vitamin D Deficiency, sponsored by Dongliang Zhang, MD. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-15.

Sponsored by Dongliang Zhang, MD · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.

Read the detailed description

This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (CKD-MBD)as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in one center will be randomized to receive oral Vitamin D2 soft capsule or Rocaltrol. A total of 200 patients will be enrolled, 100 in the Vitamin D2 group and 100 in the 1,25(OH)2 Vitamin D3 group. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin D. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, and cardiovascular diseases.

02

Conditions studied

  • Vitamin D Deficiency

Keywords

  • chronic kidney disease mineral and bone disorder
  • vitamin D2
  • parathyroid hormone
03

In context

Chronic Kidney Disease-Mineral and Bone Disorder

53 studies on the registry are indexed under Chronic Kidney Disease-Mineral and Bone Disorder; 17 are open to participants now.

This study's enrollment of 204 is above the median of 55 across 25 interventional studies indexed under Chronic Kidney Disease-Mineral and Bone Disorder.

Browse Chronic Kidney Disease-Mineral and Bone Disorder studies →

Lead sponsor

Dongliang Zhang, MD is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with age between 18-75 years.
  • Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder.

Exclusion criteria

Exclusion Criteria:

  • Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
  • New fracture in last 3 months.
  • Active system immunity diseases.
  • History of liver failure
  • History of intestinal malabsorption or chronic diarrhea
  • Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
  • Primary hyperparathyroidism
  • Treatment with cinacalcet or other calcimimetic within the past 6 months
  • Anticipated dialysis within 6 months after randomization
  • Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
  • Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
  • Current treatment with vitamin D 50,000 IU
  • Using glucocorticoid or immunosuppressive agents.
  • Acute renal dysfunction.
  • The expected live time is less than 2 years.
  • Pregnant or lactating woman.
  • Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
  • Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
204 participants (actual)

Study arms

  • Experimental
    Vitamin D2 Treatment

    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.

    Drug: Vitamin D2

  • Active comparator
    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.

    Drug: 1,25(OH)2 Vit D3

Interventions

  • DrugVitamin D2

    Treatment with Vit D2.

    Also known as: Vitamin D2 soft capsules

  • Drug1,25(OH)2 Vit D3

    Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).

    Also known as: Rocaltrol

06

What researchers measure

Primary outcomes

  1. The Blood Levels of Calcium at the 24th Month of Following up.

    The blood levels of calcium at the 24th month of following up will be detected.

    Time frame: 24 months

  2. The Blood Levels of Phosphorus at the 24th Month of Following up.

    The blood levels of phosphorus at the 24th month of following up will be detected.

    Time frame: 24 months

  3. The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.

    The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.

    Time frame: 24 months

Secondary outcomes

  1. The Blood 25(OH)Vitamin D Level.

    The levels of blood 25(OH)Vitamin D at the 24th month of following up.

    Time frame: 24 months

  2. The Incidence Rate of Secondary Hyperparathyroidism.

    Patients 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.

    Time frame: 24 months

07

Results

Posted Feb 15, 2016

Participant flow

Participant flow — Overall Study
MilestoneVitamin D21,25(OH)2 Vitamin D3
Started104100
Completed104100
Not completed00

Outcome measures

PrimaryThe Blood Levels of Calcium at the 24th Month of Following up.

The blood levels of calcium at the 24th month of following up will be detected.

Time frame:
24 months
Reported as:
Mean · mmol/L
The Blood Levels of Calcium at the 24th Month of Following up.
mmol/LVitamin D21,25(OH)2 Vitamin D3
The Blood Levels of Calcium at the 24th Month of Following up.2.31 ± 0.142.33 ± 0.14
Statistical analysis
  • Vitamin D2 · t-test, 2 sided · p = 0.117
  • 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = 0.309
  • Vitamin D2 vs 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = 0.554 (t=-0.593)
SecondaryThe Blood 25(OH)Vitamin D Level.

The levels of blood 25(OH)Vitamin D at the 24th month of following up.

Time frame:
24 months
Reported as:
Mean · ng/ml
The Blood 25(OH)Vitamin D Level.
ng/mlVitamin D21,25(OH)2 Vitamin D3
The Blood 25(OH)Vitamin D Level.37.31 ± 10.4918.07 ± 7.55
Statistical analysis
  • Vitamin D2 vs 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = <0.001
  • 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = <0.001
  • Vitamin D2 vs 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = <0.001 (P\<0.001, t=-14.982.)
SecondaryThe Incidence Rate of Secondary Hyperparathyroidism.

Patients 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.

Time frame:
24 months
Reported as:
Number · participants
The Incidence Rate of Secondary Hyperparathyroidism.
participantsVitamin D2 Treatment1,25(OH)2 Vitamin D3
The Incidence Rate of Secondary Hyperparathyroidism.1415
Statistical analysis
  • Vitamin D2 Treatment vs 1,25(OH)2 Vitamin D3 · Chi-squared · p = 0.753 (Chi-square value=0.099)
PrimaryThe Blood Levels of Phosphorus at the 24th Month of Following up.

The blood levels of phosphorus at the 24th month of following up will be detected.

Time frame:
24 months
Reported as:
Mean · mmol/L
The Blood Levels of Phosphorus at the 24th Month of Following up.
mmol/LVitamin D21,25(OH)2 Vitamin D3
The Blood Levels of Phosphorus at the 24th Month of Following up.1.27 ± 0.391.25 ± 0.33
Statistical analysis
  • Vitamin D2 · t-test, 2 sided · p = <0.001
  • 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = <0.001
  • Vitamin D2 vs 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = 0.694 (t=0.394)
PrimaryThe Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.

The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.

Time frame:
24 months
Reported as:
Mean · pg/ml
The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
pg/mlVitamin D21,25(OH)2 Vitamin D3
The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.96.5 ± 87.1108.1 ± 134.0
Statistical analysis
  • Vitamin D2 · t-test, 2 sided · p = 0.179
  • 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = 0.106
  • Vitamin D2 vs 1,25(OH)2 Vitamin D3 · t-test, 2 sided · p = 0.463 (t=-0.736)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vitamin D2—13/104 (12.5%)10/104 (9.6%)
1,25(OH)2 Vitamin D3—10/100 (10%)8/100 (8%)
Most frequent serious events
Most frequent serious events
EventVitamin D21,25(OH)2 Vitamin D3
In patientGeneral disorders7/1042/100
AMICardiac disorders2/1043/100
congestive heart failureCardiac disorders1/1043/100
StrokeNervous system disorders3/1042/100
Most frequent other events
Most frequent other events
EventVitamin D21,25(OH)2 Vitamin D3
Renal replacement therapyRenal and urinary disorders10/1048/100

Baseline characteristics

Age, Continuous
Age, Continuous(years)Vitamin D21,25(OH)2 Vitamin D3Total
Mean57.35 ± 5.6456.27 ± 5.9456.89 ± 6.76
Sex: Female, Male
Sex: Female, Male(Participants)Vitamin D21,25(OH)2 Vitamin D3Total
Female303464
Male7466140
Region of Enrollment
Region of Enrollment(participants)Vitamin D21,25(OH)2 Vitamin D3Total
China104100204
Ca-baseline
Ca-baseline(mmol/L)Vitamin D21,25(OH)2 Vitamin D3Total
Mean2.29 ± 0.142.31 ± 0.112.30 ± 0.12
P-baseline
P-baseline(mmol/L)Vitamin D21,25(OH)2 Vitamin D3Total
Mean1.15 ± 0.241.14 ± 0.211.14 ± 0.22
iPTH-baseline
iPTH-baseline(ng/ml)Vitamin D21,25(OH)2 Vitamin D3Total
Mean109.7 ± 127.889.5 ± 75.098.2 ± 100.1
25(OH)Vit D
25(OH)Vit D(ng/ml)Vitamin D21,25(OH)2 Vitamin D3Total
Mean15.14 ± 7.4614.90 ± 6.1515.02 ± 6.83
08

Study locations

1 site
  • Beijing Friedship Hospital
    Beijing, Beijing 100050, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01633853
Lead sponsor
Dongliang Zhang, MD
Collaborators
Beijing Municipal Science & Technology Commission
Responsible party
Dongliang Zhang, MD (Associate Professor, Capital Medical University) — Sponsor-investigator
First posted
Jul 4, 2012
Start date
Jul 2012
Primary completion
Sep 2015
Completion
Sep 2015
Results posted
Feb 15, 2016
Last update
Feb 15, 2016

Study contacts

Dongliang Zhang, Doctor
principal investigator · Nephrology Department of Beijing Friendship Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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