Intravenous Iron May Increase Depression Among Hemodialysis Patients

NCT03157050 | Completed DMC

• 1 other identifier: BN-13058
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depression; Hemodialysis Complication; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Intravenous iron therapy OTHER

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis patients with iron deficiency anemia.

You may qualify if:

• age was above 19 years,
• patient on maintenance hemodialysis,
• patient had iron deficiency anemia (ferritin \> 100 ng/ml)

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead
• New Jeddah Clinic Hospital: collaborator

MeSH Terms

Conditions

Depression; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mahmoud Hamada, MD

  Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine - Faculty of Medicine

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: January 14, 2016
• Primary Completion: May 15, 2017
• Study Completion: May 16, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share