Association Between Depression and Iron Metabolism in Hem... | NCT03096626

Studies
Association Between Depression and Iron Metabolism in Hemodialysis Patients

NCT03096626

Sponsor

Yoshihiro Tsuji

Status

Completed

Last Update Posted

Mar 30, 2017Actual

Enrollment

152Actual

Phase

Not provided

Conditions

Hemodialysis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Mar 1, 2017Actual

Completion Date

Mar 1, 2017Actual

First Submitted Date

Mar 24, 2017

First Submission Date that Met QC Criteria

Mar 29, 2017

First Posted Date

Mar 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2017

Last Update Posted Date

Mar 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

152Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of depression status	Using The Beck Depression Inventory	day 1

Secondary Outcomes

Measure	Description	Time Frame
The values of serum ferritin	Measuring serum ferritin levels as iron metabolism	day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study subjects were the patients undergoing HD.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuko Mizuno-Matsumoto, Ph.D	Graduate School of Applied Informatics, University of Hyogo	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided