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NCT Number: NCT00798993

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

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.

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Key information

Conditions

End Stage Kidney Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable on dialysis for at least 3 months
  • Able to obtain informed consent
  • Medically stable
  • Dialysis adequacy at target for small solute clearance (ie Kt/V>1.2 or Urea reduction ratio>65%)
  • Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline

Exclusion criteria

  • Limb Amputation
  • Impaired cognition
  • Impaired vision
  • Haemoglobin concentration < 110g/L
  • Change in Erythropoiesis stimulating agent dose over the last 2 months
  • Unable or unwilling to comply with exercise program

Treatment and study plan

Structured Exercise program

Other

30 minutes on an exercise bicycle during every dialysis

Cholecalciferol (25-Hydroxyvitamin D)

Drug

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

Usual exercise

Other

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

Primary outcomes

  1. Exercise capacity - modified shuttle walk test

    Time frame: Basesline, 3 & 6 months

Secondary outcomes

  1. Quality of life with KDQOL

    Time frame: Baseline, 3 & 6 months

  2. Quadriceps Strength

    Time frame: Baseline, 3 & 6 months

  3. Serum phosphate

    Time frame: baselibe, 3 & 6 months

  4. Feeling thermometer

    Time frame: Baseline, 3 & 6 months

  5. Timed up and go

    Time frame: baseline, 3 & 6 months

  6. Falls

    Time frame: continuous

  7. Pulse wave velocity

    Time frame: baseline, 3 & 6 months

  8. Bioimpedance

    Time frame: Baseline, 3 & 6 months

Sponsors and collaborators

Lead sponsor

Sir Charles Gairdner Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 27, 2008
Registry last updated
Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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