DepressionNCT03157050
Intravenous Iron May Increase Depression Among Hemodialysis Patients
An observational study of Depression and Hemodialysis Complication, run by Benha University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression, Hemodialysis Complication, Iron Deficiency Anemia
- What is being tested?
- Intravenous iron therapy
- Type of treatment
- Injection or infusion
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2016to 16 May 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients with iron deficiency anemia.
Who may be able to join
- age was above 19 years,
- patient on maintenance hemodialysis,
- patient had iron deficiency anemia (ferritin > 100 ng/ml)
Who cannot join
- patient has history of depression or already using antidepressant medication,
- Lack of ferritin level increase ≥ 50% from baseline level before IV iron administration,
- patient already on oral or intravenous iron supplement
About this study
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.
- Being tested
- Intravenous iron therapy
- Medical subject headings
- Depression, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous iron therapyOther
each patient with iron def anemia received an IV syringe of iron sucrose 100 mg every dialysis session for 10 doses
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient health questionnaire-9 score
change in patient health questionnaire-9 score before and after intravenous iron therapy
Measured: on day 0 of start of intravenous iron and 1 week after completion of intravenous iron
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start14 Jan 2016
- Primary completion15 May 2017
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Responsible party
- Principal investigator, Mahmoud Hamada imam, Benha University
- Investigators
- Mahmoud Hamada, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157050
- Sponsor's protocol ID
- BN-13058
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron May Increase Depression Among Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03157050
- Acronym / sponsor ID
- BN-13058
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 17 May 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients with iron deficiency anemia.
Key inclusion criteria (3 listed)
- age was above 19 years,
- patient on maintenance hemodialysis,
- patient had iron deficiency anemia (ferritin > 100 ng/ml)
Key exclusion criteria (3 listed)
- patient has history of depression or already using antidepressant medication,
- Lack of ferritin level increase ≥ 50% from baseline level before IV iron administration,
- patient already on oral or intravenous iron supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous iron therapyeach patient with iron def anemia received an IV syringe of iron sucrose 100 mg every dialysis session for 10 doses | Other | – |
Primary outcome
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
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 17 May 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.
Mahmoud Hamada, MD principal investigator
Benha University
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Hemodialysis Complication, run by Benha University.
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 3 inclusion and 3 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 17 May 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?
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). 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 17 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.