Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01988116 · ClinicalTrials.gov registry record · Early Phase 1
Effects of Vitamin D Replacement on Hormones Regulating Iron Metabolism in Individuals With Chronic Kidney Disease
A Early Phase 1 study of Chronic Kidney Disease and Anemia of Chronic Disease, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01988116 is a Early Phase 1 study of Chronic Kidney Disease and Anemia of Chronic Disease that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01988116, a Early Phase 1 study of Chronic Kidney Disease and Anemia of Chronic Disease, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of two hormones that control iron levels, hepcidin and hemojuvelin in people with chronic kidney disease (CKD). Iron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Problems with iron metabolism can lead to low blood levels (anemia), which can commonly happen in people with CKD. New research over the last decade has uncovered a new hormone called 'hepcidin', which is made in the liver and released into the blood. Hepcidin controls how much iron is in the blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to be high in people with CKD, and a recent small study in people with normal kidney function showed that treatment with vitamin D decreased hepcidin levels. Another protein, known as 'hemojuvelin', has been recently discovered and is also thought to control the amount of iron in the blood. The relationship between vitamin D and hemojuvelin has never been studied before. In this study, investigators would like to examine the effects of vitamin D on iron metabolism and blood levels of hepcidin C and hemojuvelin in individuals with CKD.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oral Calcitriol 0.5 mcg once daily for 6 weeks
Study Locations (1)
Alabama
- University of Alabama - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-06 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01988116
The ClinicalTrials.gov registry entry for NCT01988116 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01988116 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT01988116 about?
NCT01988116 is a clinical study titled "Effects of Vitamin D Replacement on Hormones Regulating Iron Metabolism in Individuals With Chronic Kidney Disease". The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of two hormones that control iron levels, hepcidin and hemojuvelin in people with chronic kidney disease (CKD). Iron is an essential mineral which is a major component of protein...
What is the current status of trial NCT01988116?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2013-10. Estimated completion is 2015-06.
What conditions does trial NCT01988116 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Anemia of Chronic Disease.
What interventions are being tested in trial NCT01988116?
The interventions under investigation include: Placebo (DRUG), Oral Calcitriol 0.5 mcg once daily for 6 weeks (DRUG).
Who is sponsoring clinical trial NCT01988116?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01988116 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
COMPLETED · Early Phase 1
-
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
RECRUITING · Phase 2
-
Patient-driven Management of BP in CKD
RECRUITING · Phase 3
-
A Natural History Study of Metabolic Sizing in Health and Disease
RECRUITING
-
Pivotal Study of the Velocity™ pAVF System
RECRUITING · NA
-
Safety of Short-course of NSAIDs in Pediatric Patients With CKD
RECRUITING · Phase 4
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.