Trials Sponsors Conditions Drugs Pricing

Conditions

Vitamin D Deficiency Malnutrition

Keywords

chronic kidney diseasemineral and bone diseaseMalnutritionVitamin Dlow 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

Interventions

1,25(OH)2 Vitamin D3Drug

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 D2Drug

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.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Beijing Municipal Science & Technology Commission
Othercollaborator
Wenhu Liu
Otherlead

Study Sites (5)

Beijing XuanWu Hospital

Beijing, Beijing Municipality, 100000, China

People's Liberation Army Air Force General Hospital

Beijing, Beijing Municipality, 100000, China

People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100000, China

Sino-Japanese Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Beijing Friedship Hospital

Beijing, Beijing Municipality, 100050, China

MeSH Terms

Conditions

Vitamin D DeficiencyMalnutritionRenal Insufficiency, ChronicCalcinosisBone Diseases

Interventions

ErgocalciferolsDiet, Protein-Restricted

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesNutrition DisordersNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic Diseases

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 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2015

Estimated (date passed)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (4)

Vitamin D2 Treatment

1,25(OH)2 Vitamin D3

low protein diet

normal protein diet

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (4)

Vitamin D2 Treatment

1,25(OH)2 Vitamin D3

low protein diet

normal protein diet

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations