Vitamin D DeficiencyPhase 4NCT01312441
Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D
A Phase 4 study testing Ergocalciferol in people with Vitamin D Deficiency and Renal Failure Chronic Requiring Hemodialysis, run by Albany College of Pharmacy and Health Sciences at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Renal Failure Chronic Requiring Hemodialysis
- What is being tested?
- Ergocalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2011to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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
Show all 10Show fewer
- Malnutrition (serum albumin < 2.5 mg/dL)
- Pregnancy, positive pregnancy test or breastfeeding
- Malignancy or other significant inflammatory disease
- HIV/AIDS
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Stratton VA Medical Center
Albany, New York, 12208
Hortense and Louis Rubin Dialysis Center
Clifton Park, New York, 12065
Hortense and Louis Rubin Dialysis Center
Saratoga Springs, New York, 12866
Hortense and Louis Rubin Dialysis Center
Troy, New York, 12180
About this study
Official title: Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D
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.
- Being tested
- Ergocalciferol, Placebo
- Keywords
- Vitamin D, Ergocalciferol
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
Also called Drisdol
Ergocalciferol capsules 50,000 IU once weekly for 6 months
PlaceboDrug
Placebo by mouth once weekly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Ergocalciferol | Experimental | Ergocalciferol 50,000 IU by mouth once weekly for 6 months Receives: Drug: Ergocalciferol |
| Placebo | Placebo comparator | Placebo by mouth once weekly for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionAug 2015
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany College of Pharmacy and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development, Hortense & Louis Rubin Dialysis Center, Satellite Healthcare
- Responsible party
- Principal investigator, Darius Mason, Albany College of Pharmacy and Health Sciences
- Investigators
- Darius L Mason, Pharm.D., Principal investigator, Albany College of Pharmacy and Health SciencesRoy Mathew, MD, Principal investigator, Stratton Veteran Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312441
- Sponsor's protocol ID
- 00741
- Other IDs
- 10-023
- Status last verified
- Jan 2016
- First submitted
- 9 Mar 2011
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D
- ClinicalTrials.gov ID
- NCT01312441
- Acronym / sponsor ID
- 00741
- Keywords
- Vitamin D, Ergocalciferol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Albany College of Pharmacy and Health SciencesUniversity, hospital or other
- Collaborators
- VA Office of Research and Development, Hortense & Louis Rubin Dialysis Center, Satellite Healthcare
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergocalciferol | Experimental | Drug: ErgocalciferolErgocalciferol 50,000 IU by mouth once weekly for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo by mouth once weekly for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgocalciferolAlso: DrisdolErgocalciferol capsules 50,000 IU once weekly for 6 months | Drug | Ergocalciferol |
| PlaceboPlacebo by mouth once weekly for 6 months | Drug | Placebo |
Primary outcome
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darius L Mason, Pharm.D. principal investigator
Albany College of Pharmacy and Health Sciences
Roy Mathew, MD principal investigator
Stratton Veteran Affairs Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergocalciferol in people with Vitamin D Deficiency and Renal Failure Chronic Requiring Hemodialysis, run by Albany College of Pharmacy and Health Sciences at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.