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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00798993

Enrollment

Registered

2008-11-27

Start date

2009-01-31

Completion date

2011-09-30

Last updated

2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Kidney Disease

Keywords

Chronic kidney failure, 25 hydroxyvitamin D, falls, exercise, quadriceps strength

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.

Interventions

OTHERStructured Exercise program

30 minutes on an exercise bicycle during every dialysis

DRUGCholecalciferol (25-Hydroxyvitamin D)

Cholecalciferol 2000U per day will be given for duration of study to all participants

OTHERUsual exercise

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Exercise capacity - modified shuttle walk test	Basesline, 3 & 6 months

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026