Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients

End Stage Kidney Disease Clinical Trial

Official title:

The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798993
• Other study ID #: SCGH25OHD2008
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2008
• Last updated: June 6, 2013
• Start date: January 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: Sir Charles Gairdner Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin D insufficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Stable on dialysis for at least 3 months

2. Able to obtain informed consent

3. Medically stable

4. Dialysis adequacy at target for small solute clearance (ie Kt/V>1.2 or Urea reduction ratio>65%)

5. Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline

Exclusion Criteria:

1. Limb Amputation

2. Impaired cognition

3. Impaired vision

4. Haemoglobin concentration < 110g/L

5. Change in Erythropoiesis stimulating agent dose over the last 2 months

6. Unable or unwilling to comply with exercise program

Study Design

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

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• Structured Exercise program
30 minutes on an exercise bicycle during every dialysis

Drug:
• Cholecalciferol (25-Hydroxyvitamin D)
Cholecalciferol 2000U per day will be given for duration of study to all participants

Other:
• Usual exercise
Participants randomised to this arm at 3 months will continue on their usual exercise routine for the remaining 3 months

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Sir Charles Gairdner Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity - modified shuttle walk test		Basesline, 3 & 6 months	No
Secondary	Quality of life with KDQOL		Baseline, 3 & 6 months	No
Secondary	Quadriceps Strength		Baseline, 3 & 6 months	No
Secondary	Serum phosphate		baselibe, 3 & 6 months	No
Secondary	Feeling thermometer		Baseline, 3 & 6 months	No
Secondary	Timed up and go		baseline, 3 & 6 months	No
Secondary	Falls		continuous	No
Secondary	Pulse wave velocity		baseline, 3 & 6 months	No
Secondary	Bioimpedance		Baseline, 3 & 6 months	No