Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease … (NCT01312441) | Clinical Trial Compass
TerminatedPhase 4
Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D
Stopped: Low enrollment
United States20 participantsStarted 2011-01
Plain-language summary
The prevalence of vitamin D deficiency increases as kidney function declines. As a result, many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown that vitamin D supplementation may improve many aspects of poor health such as heart disease and inflammatory markers. The objectives of this study are to determine how supplementing dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels can be maintained after a 6 month treatment course, and to examine the effect of ergocalciferol on biomarkers of inflammation and vascular health.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Activated vitamin D administration
* On chronic hemodialysis for ≥ 6 months
* Use of a synthetic biocompatible dialysis membrane
* 25-hydroxyvitamin D levels \< 30 ng/mL
* Corrected serum calcium \< 10.2 mg/dL
* Serum phosphate \< 7 mg/dL
* Iron replete (Ferritin \> 200 ng/mL and transferrin saturation \> 20%)
Exclusion Criteria:
* Current participation in any other investigational drug trial
* Vitamin D deficiency due to a heredity disorder
* Liver disease or failure
* Current or past treatment with ergocalciferol or cholecalciferol ≥ 2000 IU per day (within the past 6 months)
* Treatment with calcimimetics or bisphosphonates within the last 3 months
* Treatment with anti-epileptics or other medications that can effect vitamin D metabolism
* Malnutrition (serum albumin \< 2.5 mg/dL)
* Pregnancy, positive pregnancy test or breastfeeding
* Malignancy or other significant inflammatory disease
* HIV/AIDS
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
Timeframe: 12 months
Trial details
NCT IDNCT01312441
SponsorAlbany College of Pharmacy and Health Sciences