HemodialysisNCT03096626
Association Between Depression and Iron Metabolism in Hemodialysis Patients
An observational study of Hemodialysis, run by Yoshihiro Tsuji.
Trial summary
This study assesses the association of depression symptoms and iron metabolism in patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 Mar 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study subjects were the patients undergoing HD.
Who may be able to join
- Patients with stable undergoing hemodialysis
Who cannot join
- 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.
About this study
This study assesses the association of depression symptoms and iron metabolism in patients undergoing hemodialysis.
Read the 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.
- Conditions
- Hemodialysis
- Keywords
- Depression
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of depression status
Using The Beck Depression Inventory
Measured: day 1
Secondary outcomes (1)
The values of serum ferritin
Measuring serum ferritin levels as iron metabolism
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Dec 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yoshihiro Tsuji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yoshihiro Tsuji, University of Hyogo
- Investigators
- Yuko Mizuno-Matsumoto, Ph.D, Study director, Graduate School of Applied Informatics, University of Hyogo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096626
- Sponsor's protocol ID
- Uhyogo2
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2017
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Depression and Iron Metabolism in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03096626
- Acronym / sponsor ID
- Uhyogo2
- Conditions
- Hemodialysis
- Keywords
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Yoshihiro TsujiUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- 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.
This study assesses the association of depression symptoms and iron metabolism in patients undergoing hemodialysis.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study subjects were the patients undergoing HD.
Key inclusion criteria (1 listed)
- Patients with stable undergoing hemodialysis
Key exclusion criteria (1 listed)
- 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.
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
Measurement of depression status
Time frame: day 1
Using The Beck Depression Inventory
1 secondary outcome
The values of serum ferritin
Time frame: day 1
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 30 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Yuko Mizuno-Matsumoto, Ph.D study director
Graduate School of Applied Informatics, University of Hyogo
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis, run by Yoshihiro Tsuji.
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 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Measurement of depression status (time frame: day 1). 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 30 Mar 2017.