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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03157050
Other study ID # BN-13058
Secondary ID
Status Completed
Phase N/A
First received May 16, 2017
Last updated May 16, 2017
Start date January 14, 2016
Est. completion date May 16, 2017

Study information

Verified date May 2017
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date May 16, 2017
Est. primary completion date May 15, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Intervention

Other:
Intravenous iron therapy
each patient with iron def anemia received an IV syringe of iron sucrose 100 mg every dialysis session for 10 doses

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Benha University New Jeddah Clinic Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Change in patient health questionnaire-9 score 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
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