Vitamin D DeficiencyNCT01548716
A Study of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
An observational study of Vitamin D Deficiency and End Stage Renal Disease, run by Winthrop University Hospital at 2 sites in United States.
Trial summary
Hypothesis: 25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than those in HD patients with itching 25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vitamin D Deficiency, End Stage Renal Disease
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Feb 2012
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ESRD patients on hemodialysis
Who may be able to join
- Hemodialysis treatment for > 3 months No complaints of itching within 1 month prior to study enrollment
Who cannot join
- Age < 18 years
- Failure to provide informed consent
- Intact PTH < 70 pg/ml or > 1,000 pg/ml
- Serum phosphorus > 7.0
- Serum calcium (adjusted for albumin)> 11
- Active malignancy
- Likelihood of imminent renal transplantation
- Current ergocalciferol treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Winthrop University Hospital Dialysis Unit
Mineola, New York, 11023
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: A Cross-sectional Analysis of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
Hypothesis:
25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than those in HD patients with itching
25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of patients complaining of itching.
Read the detailed description
25-hydroxy vitamin D levels from non-itching HD patients in this study will be compared to 25-hydroxy vitamin D levels from our ongoing study in HD patients with itching. The primary endpoints for both studies are continuous variables. Student's t test will be used to test for statistical significance. Multiple regression analysis will be used for controlling covariates and testing the interaction among covariates.
- Conditions
- Vitamin D Deficiency, End Stage Renal Disease
- Keywords
- Pruritis in hemodialysis patients, 25-Vitamin D in chronic kidney disease
- Medical subject headings
- Vitamin D Deficiency, Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
25 hydroxy vitamin D level
Pt will have blood sample taken and fill out 1) Pruritis Survey 2) Phosphorus Restriction Compliance Survey
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2011
- Study completionFeb 2012
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Responsible party
- Principal investigator, Mary Schanler, Winthrop University Hospital
- Investigators
- Mary Schanler, RD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548716
- Sponsor's protocol ID
- 11318
- Status last verified
- Mar 2012
- First submitted
- 24 Feb 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Analysis of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01548716
- Acronym / sponsor ID
- 11318
- Conditions
- Vitamin D Deficiency, End Stage Renal Disease
- Keywords
- Pruritis in hemodialysis patients, 25-Vitamin D in chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Study start
- Sep 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Mar 2012 (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.
Hypothesis:
25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than those in HD patients with itching
25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of patients complaining of itching.
Detailed description
25-hydroxy vitamin D levels from non-itching HD patients in this study will be compared to 25-hydroxy vitamin D levels from our ongoing study in HD patients with itching. The primary endpoints for both studies are continuous variables. Student's t test will be used to test for statistical significance. Multiple regression analysis will be used for controlling covariates and testing the interaction among covariates.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ESRD patients on hemodialysis
Key inclusion criteria (1 listed)
- Hemodialysis treatment for > 3 months No complaints of itching within 1 month prior to study enrollment
Key exclusion criteria (8 listed)
- Age < 18 years
- Failure to provide informed consent
- Intact PTH < 70 pg/ml or > 1,000 pg/ml
- Serum phosphorus > 7.0
- Serum calcium (adjusted for albumin)> 11
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
25 hydroxy vitamin D level
Time frame: up to 2 weeks
Pt will have blood sample taken and fill out 1) Pruritis Survey 2) Phosphorus Restriction Compliance Survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
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.
Mary Schanler, RD principal investigator
Winthrop University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and End Stage Renal Disease, run by Winthrop University Hospital at 2 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
25 hydroxy vitamin D level (time frame: up to 2 weeks). 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 8 Mar 2012.