Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition

Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02005302

Enrollment

600

Registered

2013-12-09

Start date

2013-01-31

Completion date

2016-12-31

Last updated

2013-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency, Malnutrition

Keywords

chronic kidney disease, mineral and bone disease, Malnutrition, Vitamin D, low protein diet

Brief summary

Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.

Detailed description

This study will enroll chronic kidney disease patients, stage 3 to 5ND, who have chronic kidney disease mineral and bone disease (CKD-MBD) and malnutrition as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in five centers will be randomized. A total of 600 patients will be enrolled, 150 patients receiving Vitamin D2 treatment virus 150 patients receiving calcitriol treatment, and another 150 patients receiving low protein diet virus 150 patients receiving normal protein diet. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, 25 hydroxyvitamin D, albumin and hemoglobin. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, cardiovascular diseases, nutritional status and quality of life.

Interventions

DRUG1,25(OH)2 Vitamin D3

Oral 1,25(OH)2 Vitamin D3 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.

DRUGVitamin 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.

DIETARY_SUPPLEMENTlow protein diet

Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of 0.6g-0.8g/kg/d.

DIETARY_SUPPLEMENTnormal protein diet

Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of more than 0.8g/kg/d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with age between 18-80 years. * Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder and malnutrition

Exclusion criteria

* Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system. * 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.

Design outcomes

Primary

Measure	Time frame	Description
The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months	36 months	The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline.
The changes on the clinical indicators of nutritional status	36 months	The blood levels of albumin, prealbumin, transferrin and hemoglobin will be detected every three months. The values during follow-up will be compared to the baseline.

Secondary

Measure	Time frame	Description
The changes of the blood 25(OH)Vitamin D level	36 months	—
The changes of the quality of life	36 months	Assess the quality of life for patients in accordance with KDQOL-SF scale every 6 month. The values during follow-up will be compared to the baseline.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026