Skip to main content
OpenTrials
Completed

NCT Number: NCT01214928

Hemodialysis Vitamin D Pilot

Vitamin D is a prohormone obtained through diet, supplementation, or sun exposure. Once absorbed, this nutritional vitamin D undergoes a two-step reaction in the liver and in the kidney to become the active hormone, calcitriol. Besides the kidney, many other body tissues are capable of local vitamin D activation. This local tissue activity is important for maintenance of health and relies on adequate levels of nutritional vitamin D. Not only are dialysis patients deficient in calcitriol due to kidney failure, but they are also deficiency in nutritional vitamin D. Low levels of vitamin D have been associated with higher rates of death, heart and blood vessel disease, osteoporosis, falls, cancer, and autoimmune diseases. Despite this, there is a lack of randomized controlled trials (RCT) examining the effects of nutritional vitamin D in hemodialysis (HD) patients. The investigators hypothesize that long-term supplementation with nutritional vitamin D in HD patients improves survival and cardiovascular outcomes. Before embarking on a large scale RCT, the investigators propose a small pilot RCT with 20 hemodialysis patients to: i) To determine the effects of cholecalciferol (vitamin D3) in raising blood vitamin D levels; ii) To determine the feasibility and barriers to successful randomization and adherence to treatment protocols, which will inform subsequent studies.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant is ≥ 18 years
  • Participant is on hemodialysis ≥ 3 months

Exclusion criteria

  • Serum calcium >2.75 mmol/L
  • On concurrent vitamin D treatment ≥ 800 IU/day. Includes ergocalciferol, cholecalciferol, calcedidiol, over-the-counter vitamin D. Does not include one-alpha calcidol (One Alfa®) or 1, 25 di-hydroxy-D3 (Rocaltrol® or Calcijex®)
  • Known hypersensitivity or allergy to Vitamin D
  • End stage liver disease
  • Severe untreated malabsorption or resection of large segment of small bowel
  • Lack of informed consent or inability to consent
  • Currently enrolled in a RCT

Treatment and study plan

Cholecalciferol

Drug

cholecalciferol 50,000 IU po once weekly for 12 weeks

Other names: vitamin D3

Primary outcomes

  1. Feasibility objectives for this proof-of-concept study

    Time frame: 1 year

    • To determine the proportion of consecutive HD patients that are eligible, the proportion of eligible patients that will consent to randomization, and of those randomized, the proportion that will comply with their group assignment.
    • To determine the treatment effect of oral cholecalciferol compared with placebo in raising serum 25(OH)D and 1,25(OH)2D levels in HD patients.

Secondary outcomes

  1. Six Minute Walk Test

    Time frame: 1 year

    • To determine the proportion of eligible patients that are able to complete a baseline and end of study 6-minute walk test.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Jul 20, 2011

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.

Published trials that share one or more normalized conditions with this study.