Intravenous Iron May Increase Depression Among Hemodialysis Patients

May 16, 2017 updated by: Mahmoud Hamada imam, Benha University
the aim of this study is to assess whether increased ferritin after intravenous iron therapy will lead to increased prevalence of major depression among treated patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

112

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemodialysis patients with iron deficiency anemia.

Description

Inclusion Criteria:

  1. age was above 19 years,
  2. patient on maintenance hemodialysis,
  3. patient had iron deficiency anemia (ferritin > 100 ng/ml)

Exclusion Criteria:

  1. patient has history of depression or already using antidepressant medication,
  2. Lack of ferritin level increase ≥ 50% from baseline level before IV iron administration,
  3. patient already on oral or intravenous iron supplement

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: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient health questionnaire-9 score
Time Frame: on day 0 of start of intravenous iron and 1 week after completion of intravenous iron
change in patient health questionnaire-9 score before and after intravenous iron therapy
on day 0 of start of intravenous iron and 1 week after completion of intravenous iron

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Collaborators

New Jeddah Clinic Hospital

Investigators

  • Principal Investigator: Mahmoud Hamada, MD, Benha University

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)

January 14, 2016

Primary Completion (Actual)

May 15, 2017

Study Completion (Actual)

May 16, 2017

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BN-13058

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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