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

NCT02005302 | Unknown Phase 4 DMC

• 2 other identifiers: BJFH-EC/2013-076D131100004713001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

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.

Conditions

Vitamin D Deficiency; Malnutrition

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 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.

  36 months

• The changes on the clinical indicators of nutritional status

  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.

  36 months

Secondary Outcomes (2)

• The changes of the blood 25(OH)Vitamin D level

  36 months

• The changes of the quality of life

  36 months

Study Arms (4)

Vitamin D2 Treatment

EXPERIMENTAL

Drug: Vitamin D2

1,25(OH)2 Vitamin D3

ACTIVE COMPARATOR

Drug: 1,25(OH)2 Vitamin D3

low protein diet

EXPERIMENTAL

Dietary Supplement: low protein diet

normal protein diet

ACTIVE COMPARATOR

Dietary Supplement: normal protein diet

Interventions

1,25(OH)2 Vitamin D3 DRUG

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.

Also known as: Active Vit D3

1,25(OH)2 Vitamin D3

Vitamin D2 DRUG

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.

Also known as: Vit D2

Vitamin D2 Treatment

low protein diet DIETARY_SUPPLEMENT

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.

low protein diet

normal protein diet DIETARY_SUPPLEMENT

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.

normal protein diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenhu Liu: lead
• Beijing Municipal Science & Technology Commission: collaborator

Study Sites (5)

Beijing XuanWu Hospital

Beijing, Beijing Municipality, 100000, China

Location

People's Liberation Army Air Force General Hospital

Beijing, Beijing Municipality, 100000, China

Location

People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100000, China

Location

Sino-Japanese Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Beijing Friedship Hospital

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Malnutrition; Renal Insufficiency, Chronic; Calcinosis; Bone Diseases

Interventions

Ergocalciferols; Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Wenhu Liu, Doctor

  Nephrology Department of Beijing Friendship Hospita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

CN (5)