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

Phase 4

Completed

• Conditions: End Stage Kidney Disease
• Interventions: Drug: Cholecalciferol (25-Hydroxyvitamin D); Other: Structured Exercise program; Other: Usual exercise

• Registration Number: NCT00798993
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Study Start: 2009-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Cholecalciferol (25-Hydroxyvitamin D)	Cholecalciferol 2000U per day will be given to all participants for the duration of the study
Structured exercise program	Structured Exercise program	Participants will be randomised at 3 months into either this group or the comparator of usual exercise.
Usual exercise	Usual exercise	Participants randomised to this arm, at 3 months, will continue on their usual exercise routine

Primary Outcome Measures

Name	Time	Method
Exercise capacity - modified shuttle walk test	Basesline, 3 & 6 months

Secondary Outcome Measures

Name	Time	Method
Bioimpedance	Baseline, 3 & 6 months
Serum phosphate	baselibe, 3 & 6 months
Feeling thermometer	Baseline, 3 & 6 months
Timed up and go	baseline, 3 & 6 months
Falls	continuous
Pulse wave velocity	baseline, 3 & 6 months
Quality of life with KDQOL	Baseline, 3 & 6 months
Quadriceps Strength	Baseline, 3 & 6 months

Trial Locations

Locations (1)

Sir Charles Gairdner Hospital; 🇦🇺 Perth, Western Australia, Australia