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Effects of Oral Iron on Postoperative Fatigue Upon Coronary Artery Bypass Graft Patients

NCT01912261 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2019-07-26

No results posted yet for this study

Summary

The purpose of this research study is to examine how an oral iron supplement (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and, the effects on recovery outcomes (e.g. quality of life, functional capacity, anemia, and medication adherence).

It is hypothesized that CABG surgery patients receiving oral iron (Feramax®) 150mg orally (once a day therapy) will have a 15% reduction in POF (measured by the Identity Consequence Fatigue Scale (ICFS)), compared to patients receiving a placebo.

Conditions

Interventions

DRUG

Placebo

one capsule orally daily times 84 days

DRUG

Polysaccharide iron complex

150 mg daily orally times 84 days

Sponsors & Collaborators

  • Capital Health, Canada

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Blaine Kent, MD · Capital Health, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-16
Primary Completion
2018-02-21
Completion
2019-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01912261 on ClinicalTrials.gov