FatiguePhase 3NCT01912261
Effects of Oral Iron on Postoperative Fatigue Upon Coronary Artery Bypass Graft Patients
A Phase 3 study testing Polysaccharide iron complex in people with Fatigue, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Fatigue
- What is being tested?
- Polysaccharide iron complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- 16 Dec 2014to Feb 2019
- Phase
- Phase 3
- 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
Who may be able to join
- Non-Urgent, first time, coronary artery bypass grafting.
- American Society of Anesthesia (ASA) physical status II-IV
- Aged 19 years and older
- Able to make informed consent by understanding the nature of the participation
- Able to read and write English to the degree necessary to participate in interviews and questionnaires
Who cannot join
- Had prior median sternotomy surgery
- A Hemoglobin greater than or equal 120g/L at discharge
- Previous history of noncompliance with oral medications
- Received erythropoiesis-stimulating agents (e.g. epoetin alfa and darbepoetin alfa) postoperatively to discharge
- Allergy to iron History of hematological disorders that are deemed clinically significant as per the investigator's clinical judgment
- Received Clopidogrel within two days prior to surgery, greater than 81mg of Acetylsalicylic acid 24 hours prior to surgery, or have received "new oral anticoagulants" (e.g. Apixaban, Rivaroxaban, and Dabigatran) within the recommended preoperative exclusion period
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- History of iron metabolism disorders e.g. known iron overload, hemochromatosis, porphyria
- Chronic fatigue syndrome (a condition that is distinguished from other types of fatigue by fatigue lasting more than six months and has at least four other symptoms (e.g. sleep disturbances, headaches, joint pain, and concentration difficulties) that could contribute to increased fatigue (Afari \& Buchwald, 2003)).
- A serum transferrin saturation of more than 50% at discharge
- History of Fibromyalgia
- Current diagnosis of depressive disorder
- History of Hypothyroidism includes uncontrolled thyroid disease (abnormal Thyroid Stimulating Hormone (TSH) or Thyroxine (T4) at screening visit) as per the Investigator's clinical judgment
- Patient taking iron supplementation ≤ 60 days before surgery and in the postoperative period
- Any other unstable conditions as per the Investigator's clinical judgment
- Contraindications to the six-minute walk test
- Physical disability preventing safe performance
- Resting heart rate > 120 beats/min 10 min after rest (relative contraindications)
- Systolic blood pressure >180mm ± Diastolic blood pressure > 100mm Hg (relative contraindications)
- Resting Sp02 <85% on room air or on a prescribed level of supplemental oxygen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Randomized Double Blind Placebo-Controlled Study To Assess The Effects Of FeraMax When Administered Orally Once A Day On Postoperative Fatigue Levels In Patients Following Elective Coronary Artery Bypass Graft Surgery (CABG)
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.
Read the detailed description
Postoperative fatigue (POF) is one of the main complaints in approximately 39-80% of CABG surgery patients. POF can have a significant impact on an individual's quality of life (QoL) and recovery. The objectives are to examine how an oral iron (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and determine the effects on recovery outcomes (e.g. QoL, functional capacity, anemia, and medication adherence). To achieve these objectives the research will aim to answer the following questions:
- Is oral iron effective in reducing POF measured by the Identity Consequence Fatigue Scale (ICFS) over 12 weeks?
- If oral iron is effective, how effective was it on improving fatigue, functional capacity, QoL, and anemia?
- To what degree do patients taking oral iron adhere to the prescription? A prospective, randomized, double-blind placebo-controlled, single-center study was chosen for this study. Three hundred participants who are scheduled for an isolated CABG surgery will be recruited from the QEII Health Sciences Centre (QEIIHSC), Halifax, Nova Scotia. All study participants will be followed for three months following hospital discharge.
Data will be collected at five time points:
Time point 1 Baseline -Patients are screened in the preadmission clinic or nursing unit and recruited for the study. During this visit, the patient will be assessed for eligibility, demographic data and blood work collected and three questionnaires and six minute walk test completed by participants.
Time point 2 Discharge/Randomization-Patients will be randomized to either FeraMAX® or placebo at hospital discharge. The treatment will be taken once daily for 84 days starting Day 1 (day after discharge from hospital). The questionnaires, six minute walk test and blood work will be repeated.
Time point 3 -Post testing 7 to 14 days post discharge A follow up telephone call to reminder patients to take medications and fill put side effects diary
Time Point 4 Six week Follow up-Blood work will be collected and three questionnaires and six minute walk test completed by participants.
Time Point 5-End of treatment-The questionnaires, six minute walk test, blood work, collect side effects diary and pill count will be repeated during a clinic visit.
Fatigue will be measured with the ICFS and Functional Assessment of Cancer Therapy Anemia( FACT-An) questionnaire. The Short Form-36 is used to measure QoL and the six minute walk test to measure functional capacity. Standard of care laboratory tests including (hemoglobin (Hgb) level, reticulocyte count, ferritin, iron, total iron binding capacity (TIBC), transferrin saturation, and C-Reactive Protein levels will be drawn. Medication adherence to the will be assessed by pill count.
The primary endpoint will be analyzed using ANOVA for repeated measures to compare level of fatigue of two groups at baseline, discharge, six weeks and 12 weeks. For the secondary endpoint, a subgroup analysis will be performed and reported on participants with and without iron- deficiency anemia to determine if any efficacy of iron on POF is restricted to this population or to a more general population post CABG surgery. Results will be reported using mean and standard deviation when appropriate and median (interquartile range) for nonparametric data. Categorical variables will be compared using Fisher exact test or t test when appropriate. Level of significance was set at p < 0.05.
Oral iron is inexpensive and effective treatment for iron deficiency that occurs from surgical blood loss. Currently there is no specific drug used to treat POF. Standard of care for POF consists of treating and eliminating the underlying symptoms.
- Conditions
- Fatigue
- Being tested
- Placebo, Polysaccharide iron complex
- Keywords
- Coronary artery bypass grafting, Anemia, Postoperative fatigue, Functional Capacity, Iron, Adherence, Quality of Life
- Medical subject headings
- Fatigue, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar pill
one capsule orally daily times 84 days
Polysaccharide iron complexDrug
Also called FeraMAX
150 mg daily orally times 84 days
| Study group | Role | What they receive |
|---|---|---|
| FeraMax | Active comparator | FeraMax Polysaccharide iron complex oral iron supplement 150mg one capsule orally daily Receives: Drug: Polysaccharide iron complex |
| Placebo | Placebo comparator | one capsule orally daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Level
Identity Consequence Fatigue scale
Measured: 12 weeks after surgery
Secondary outcomes (4)
Health Related Quality of Life
Self Report Scale Medical Outcomes Study short Form 36 to measure Quality of Life
Measured: 12 weeks after discharge from hospital
Anemia
Functional Assessment of Cancer Therapy - Anemia Version 4 and Hemoglobin levels
Measured: 12 week after surgery
Functional Capacity
Six Minute Walk Test
Measured: 12 weeks after surgery
Medication Adherence
Pill Count
Measured: 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study start16 Dec 2014
- Primary completion21 Feb 2018
- Study completionFeb 2019
Why it stopped: The study was stopped due to time constraints and resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Health, Canada, Dalhousie University
- Responsible party
- Principal investigator, Blaine Kent MD, Nova Scotia Health Authority
- Investigators
- Blaine Kent, MD, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912261
- Sponsor's protocol ID
- TheEffectsofOral Iron052013
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2013
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Double Blind Placebo-Controlled Study To Assess The Effects Of FeraMax When Administered Orally Once A Day On Postoperative Fatigue Levels In Patients Following Elective Coronary Artery Bypass Graft Surgery (CABG)
- ClinicalTrials.gov ID
- NCT01912261
- Acronym / sponsor ID
- TheEffectsofOral Iron052013
- Conditions
- Fatigue
- Keywords
- Coronary artery bypass grafting, Anemia, Postoperative fatigue, Functional Capacity, Iron, Adherence, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to time constraints and resources
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Capital Health, Canada, Dalhousie University
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 31 Jul 2013 (estimated)
- 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 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.
Detailed description
Postoperative fatigue (POF) is one of the main complaints in approximately 39-80% of CABG surgery patients. POF can have a significant impact on an individual's quality of life (QoL) and recovery. The objectives are to examine how an oral iron (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and determine the effects on recovery outcomes (e.g. QoL, functional capacity, anemia, and medication adherence). To achieve these objectives the research will aim to answer the following questions:
- Is oral iron effective in reducing POF measured by the Identity Consequence Fatigue Scale (ICFS) over 12 weeks?
- If oral iron is effective, how effective was it on improving fatigue, functional capacity, QoL, and anemia?
- To what degree do patients taking oral iron adhere to the prescription? A prospective, randomized, double-blind placebo-controlled, single-center study was chosen for this study. Three hundred participants who are scheduled for an isolated CABG surgery will be recruited from the QEII Health Sciences Centre (QEIIHSC), Halifax, Nova Scotia. All study participants will be followed for three months following hospital discharge.
Data will be collected at five time points:
Time point 1 Baseline -Patients are screened in the preadmission clinic or nursing unit and recruited for the study. During this visit, the patient will be assessed for eligibility, demographic data and blood work collected and three questionnaires and six minute walk test completed by participants.
Time point 2 Discharge/Randomization-Patients will be randomized to either FeraMAX® or placebo at hospital discharge. The treatment will be taken once daily for 84 days starting Day 1 (day after discharge from hospital). The questionnaires, six minute walk test and blood work will be repeated.
Time point 3 -Post testing 7 to 14 days post discharge A follow up telephone call to reminder patients to take medications and fill put side effects diary
Time Point 4 Six week Follow up-Blood work will be collected and three questionnaires and six minute walk test completed by participants.
Time Point 5-End of treatment-The questionnaires, six minute walk test, blood work, collect side effects diary and pill count will be repeated during a clinic visit.
Fatigue will be measured with the ICFS and Functional Assessment of Cancer Therapy Anemia( FACT-An) questionnaire. The Short Form-36 is used to measure QoL and the six minute walk test to measure functional capacity. Standard of care laboratory tests including (hemoglobin (Hgb) level, reticulocyte count, ferritin, iron, total iron binding capacity (TIBC), transferrin saturation, and C-Reactive Protein levels will be drawn. Medication adherence to the will be assessed by pill count.
The primary endpoint will be analyzed using ANOVA for repeated measures to compare level of fatigue of two groups at baseline, discharge, six weeks and 12 weeks. For the secondary endpoint, a subgroup analysis will be performed and reported on participants with and without iron- deficiency anemia to determine if any efficacy of iron on POF is restricted to this population or to a more general population post CABG surgery. Results will be reported using mean and standard deviation when appropriate and median (interquartile range) for nonparametric data. Categorical variables will be compared using Fisher exact test or t test when appropriate. Level of significance was set at p < 0.05.
Oral iron is inexpensive and effective treatment for iron deficiency that occurs from surgical blood loss. Currently there is no specific drug used to treat POF. Standard of care for POF consists of treating and eliminating the underlying symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FeraMax | Active comparator | Drug: Polysaccharide iron complexFeraMax Polysaccharide iron complex oral iron supplement 150mg one capsule orally daily |
| Placebo | Placebo comparator | Drug: Placeboone capsule orally daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-Urgent, first time, coronary artery bypass grafting.
- American Society of Anesthesia (ASA) physical status II-IV
- Aged 19 years and older
- Able to make informed consent by understanding the nature of the participation
- Able to read and write English to the degree necessary to participate in interviews and questionnaires
Key exclusion criteria (19 listed)
- Had prior median sternotomy surgery
- A Hemoglobin greater than or equal 120g/L at discharge
- Previous history of noncompliance with oral medications
- Received erythropoiesis-stimulating agents (e.g. epoetin alfa and darbepoetin alfa) postoperatively to discharge
- Allergy to iron History of hematological disorders that are deemed clinically significant as per the investigator's clinical judgment
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 |
|---|---|---|
| PlaceboAlso: Sugar pillone capsule orally daily times 84 days | Drug | Placebo |
| Polysaccharide iron complexAlso: FeraMAX150 mg daily orally times 84 days | Drug | FeraMax |
Primary outcome
Fatigue Level
Time frame: 12 weeks after surgery
Identity Consequence Fatigue scale
4 secondary outcomes
Health Related Quality of Life
Time frame: 12 weeks after discharge from hospital
Anemia
Time frame: 12 week after surgery
Functional Capacity
Time frame: 12 weeks after surgery
Medication Adherence
Time frame: 12 weeks after surgery
Results and safety
The study was stopped early (reason given: The study was stopped due to time constraints and resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- 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.
Blaine Kent, MD principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polysaccharide iron complex in people with Fatigue, run by Nova Scotia Health Authority at 1 site in Canada.
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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to time constraints and resources). Results are not available in the source record.
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?
Fatigue Level (time frame: 12 weeks after surgery). 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 26 Jul 2019.