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

Vitamin D Deficiency Clinical Trial

Official title:

Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633853
• Other study ID #: 2012-078
• Secondary ID: Z121107001012138
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2012
• Last updated: January 16, 2016
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency, Chronic
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D2
Treatment with Vit D2.
• 1,25(OH)2 Vit D3
Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).

Locations

Country	Name	City	State
China	Beijing Friedship Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Dongliang Zhang, MD	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months	No
Primary	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.	24 months	No
Primary	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.	24 months	No
Secondary	The Blood 25(OH)Vitamin D Level.	The levels of blood 25(OH)Vitamin D at the 24th month of following up.	24 months	No
Secondary	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.	24 months	No