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NCT01532349 · ClinicalTrials.gov registry record · Phase 2
Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease
A Phase 2 study of Anemia of Chronic Kidney Disease, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01532349: Completed Phase 2 study of Anemia of Chronic Kidney Disease, sponsored by Johns Hopkins University.
NCT01532349 is a Phase 2 study of Anemia of Chronic Kidney Disease that has completed, run by Johns Hopkins University. The registered enrollment target is 34 participants, below the 653-participant average among 4 other Anemia of Chronic Kidney Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532349, a Phase 2 study of Anemia of Chronic Kidney Disease, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This research is being done to study the effectiveness of vitamin D (cholecalciferol) to modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common problem in children with CKD. Anemia is when the body does not have enough healthy red blood cells. Hepcidin is a protein in the blood which interferes with the body's production of red blood cells. This study will see if vitamin D lowers hepcidin levels in children and young adults with CKD. If so, it could be used as an additional treatment for anemia in these children, in addition to the current therapies already in use including iron supplements and erythropoietin. People between the ages of 1 and 21 with CKD may be considered for this study.
Primary Outcome
The null hypothesis to be tested is that Vitamin D supplementation will not be associated with a decrease in serum hepcidin over the study period. Statistical analysis will be performed as intention-to-treat.
Conditions Studied
Interventions
- DRUG Cholecalciferol
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01532349 record still lists
NCT01532349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 653-participant average among 4 other Anemia of Chronic Kidney Disease trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Anemia of Chronic Kidney Disease appearing as the primary indexed condition, and to 1 intervention - of which Cholecalciferol is the first listed.
NCT01532349 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01532349 about?
NCT01532349 is a clinical study titled "Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease". This research is being done to study the effectiveness of vitamin D (cholecalciferol) to modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common problem in children with CKD. Anemia is when the body does not have enough healthy red blood cells. Hepcidin is a protein ...
What is the current status of trial NCT01532349?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2012-05. Estimated completion is 2015-04.
What conditions does trial NCT01532349 study?
This clinical trial studies the following conditions: Anemia of Chronic Kidney Disease.
What interventions are being tested in trial NCT01532349?
The interventions under investigation include: Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT01532349?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01532349 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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