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

Sir Charles Gairdner Hospital

Status and phase: Completed; Phase 4

Conditions: End Stage Kidney Disease

Treatments: Other: Usual exercise; Other: Structured Exercise program; Drug: Cholecalciferol (25-Hydroxyvitamin D)

Study type: Interventional

Funder types: Other

Identifiers

NCT00798993

SCGH25OHD2008

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 3 patient groups, including a placebo group

Structured exercise program

Active Comparator group

Description:

Participants will be randomised at 3 months into either this group or the comparator of usual exercise.

Treatment:

Other: Structured Exercise program

Vitamin D

Experimental group

Description:

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

Treatment:

Drug: Cholecalciferol (25-Hydroxyvitamin D)

Usual exercise

Placebo Comparator group

Description:

Participants randomised to this arm, at 3 months, will continue on their usual exercise routine

Treatment:

Other: Usual exercise