- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03096626
Association Between Depression and Iron Metabolism in Hemodialysis Patients
March 29, 2017 updated by: Yoshihiro Tsuji
This study assesses the association of depression symptoms and iron metabolism in patients undergoing hemodialysis.
Study Overview
Status
Completed
Conditions
Detailed Description
The Beck Depression Inventory (BDI), second version, was used to quantify the levels of depression.
Mean age, duration of HD, hemoglobin levels, serum ferritin levels, serum iron levels, TSAT, TIBC, serum albumin levels, CRP and energy consumption (kcal/week) were included in the model as multivariate variables.
Backward stepwise logistic regression (ROC) analysis was performed.
Study Type
Observational
Enrollment (Actual)
152
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study subjects were the patients undergoing HD.
Description
Inclusion Criteria:
- Patients with stable undergoing hemodialysis
Exclusion Criteria:
- Patients those who refused to join present study, and those who could not complete the questionnaires by themselves, and the patients with chronic hepatitis B or C were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of depression status
Time Frame: day 1
|
Using The Beck Depression Inventory
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The values of serum ferritin
Time Frame: day 1
|
Measuring serum ferritin levels as iron metabolism
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yuko Mizuno-Matsumoto, Ph.D, Graduate School of Applied Informatics, University of Hyogo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
March 24, 2017
First Submitted That Met QC Criteria
March 29, 2017
First Posted (Actual)
March 30, 2017
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
March 29, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uhyogo2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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