Clinical trial NCT01214928: Hemodialysis Vitamin D Pilot
Official title: Oral Cholecalciferol (Vitamin D3) Therapy in Prevalent Hemodialysis Patients: A Randomized Placebo Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Renal Failure Chronic Requiring Hemodialysis
Keywords: vitamin D
cholecalciferol
hemodialysis
randomized controlled trial
pilot
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2010-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Participant is ≥ 18 years
2. Participant is on hemodialysis ≥ 3 months

   Exclusion Criteria:
3. Serum calcium \>2.75 mmol/L
4. 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®)
5. Known hypersensitivity or allergy to Vitamin D
6. End stage liver disease
7. Severe untreated malabsorption or resection of large segment of small bowel
8. Lack of informed consent or inability to consent
9. Currently enrolled in a RCT

Primary outcomes:
measure: Feasibility objectives for this proof-of-concept study
timeFrame: 1 year
Secondary outcomes:
measure: Six Minute Walk Test
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care London
name: Karen CY To, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Health Care London
name: Catherine Clase, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Health Care London
name: Azim S Gangji, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: