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

NCT02005302 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-12-09

No results posted yet for this study

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.

Conditions

  • Vitamin D Deficiency
  • Malnutrition

Interventions

DRUG

1,25(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.

DRUG

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.

DIETARY_SUPPLEMENT

low 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_SUPPLEMENT

normal 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.

Sponsors & Collaborators

  • Beijing Municipal Science & Technology Commission

    collaborator OTHER

  • Wenhu Liu

    lead OTHER

Principal Investigators

  • Wenhu Liu, Doctor · Nephrology Department of Beijing Friendship Hospita

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02005302 on ClinicalTrials.gov