Chronic Kidney DiseaseNCT00411294
Ergocalciferol in Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Saint Louis VA Medical Center at 1 site in United States.
Trial summary
To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in patients with CKD stage 3 and 4 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with CKD stage 3 or 4 whose 25-hydroxyvitamin D levels are below 30 ng/ml and plasma intact PTH levels >70 pg/ml.
Who cannot join
- Patients who are on any form of active vitamin treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis VA Medical Center
St Louis, Missouri, 63104
About this study
Official title: The Effect of Ergocalciferol Treatment on 25-Hydroxyvitamin D Levels and Plasma Intact PTH in Patients With Chronic Kidney Disease Stage 3 and 4
To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in patients with CKD stage 3 and 4
- Conditions
- Chronic Kidney Disease
- Keywords
- ergocalciferol, chronic kidney disease, secondary hyperparathyroidism, vitamin D deficiency
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary, Vitamin D Deficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Defined population
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Saint Louis VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- Ziyad Al-Aly, M.D., Principal investigator, VAMC-Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411294
- Sponsor's protocol ID
- ZA-01
- Status last verified
- Dec 2006
- First submitted
- 11 Dec 2006
- Last updated
- 13 Dec 2006
- Results posted
- No
Publications
Al-Aly Z, Qazi RA, Gonzalez EA, Zeringue A, Martin KJ. Changes in serum 25-hydroxyvitamin D and plasma intact PTH levels following treatment with ergocalciferol in patients with CKD. Am J Kidney Dis. 2007 Jul;50(1):59-68. doi: 10.1053/j.ajkd.2007.04.010.
PubMed 17591525
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ergocalciferol Treatment on 25-Hydroxyvitamin D Levels and Plasma Intact PTH in Patients With Chronic Kidney Disease Stage 3 and 4
- ClinicalTrials.gov ID
- NCT00411294
- Acronym / sponsor ID
- ZA-01
- Conditions
- Chronic Kidney Disease
- Keywords
- ergocalciferol, chronic kidney disease, secondary hyperparathyroidism, vitamin D deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Saint Louis VA Medical CenterUS federal agency
- First posted
- 13 Dec 2006 (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.
To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in patients with CKD stage 3 and 4
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with CKD stage 3 or 4 whose 25-hydroxyvitamin D levels are below 30 ng/ml and plasma intact PTH levels >70 pg/ml.
Key exclusion criteria (1 listed)
- Patients who are on any form of active vitamin treatment
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
Not reported in the source record.
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 13 Dec 2006.
- Derived from this study: PubMed 17591525Al-Aly Z, Qazi RA, Gonzalez EA, Zeringue A, Martin KJ. Changes in serum 25-hydroxyvitamin D and plasma intact PTH levels following treatment with ergocalciferol in patients with CKD. Am J Kidney Dis. 2007 Jul;50(1):59-68. doi: 10.1053/j.ajkd.2007.04.010.
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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.
Ziyad Al-Aly, M.D. principal investigator
VAMC-Saint Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Saint Louis VA Medical Center at 1 site 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 1 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 13 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00411294, which also lists 1 linked publication.
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 13 Dec 2006.