Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. Patients with iron deficiency (ID) and IDA can present with a multitude of symptoms including fatigue, restless legs syndrome and pica.Oral iron supplementation is associated with increasing hemoglobin in multiple studies in women, pregnant women and elderly patients.However, the optimal dose and frequency of oral iron supplementation for treatment remains unclear. The current proposed study attempts to address this gap in the literature.
This is a pilot, pragmatic, non-inferiority, open label randomized controlled trial (RCT) in outpatients with iron deficiency anemia to evaluate the effectiveness of oral ferrous sulfate 300mg (60mg elemental iron) once daily versus every other day to improve hemoglobin at 12 weeks post-initiation. The rationale for this study includes: (1) IDA is a common and prevalent condition with potential adverse consequences if left untreated; (2) optimizing effectiveness of oral iron supplementation while minimizing side effects will improve treatment for patients.
Because IDA is a global health problem, common in clinical practice and treatable, this study will have a significant practical impact on how clinicians treat outpatients with iron deficiency anemia and how patients tolerate therapy.
For the patient, the expected benefit from taking part in this study is the potential to improve and treat iron deficiency anemia. These potential changes may lead to improved symptoms associated with iron deficiency anemia, such as cognitive and physical functioning, and fatigue.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous Sulfate and Vitamin C every other day | Experimental | Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks |
|
| Ferrous Sulfate and Vitamin C daily | Active Comparator | Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Sulfate 300Mg Tablet | Drug | oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Enrolling Patients in the Trial | Enrollment in the trial will be defined as documentation of informed consent for patients approached. The primary outcome of this study is the feasibility of enrolling 52 participants in the trial over a 2-year period. Eligibility based on lab criteria was determined after consent. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Eligible Participants Consenting | Proportion of eligible patients after initial inclusion/exclusion screening that consent to participating in the study. Eligibility based on lab criteria was determined after consent. | 2 years |
| Proportion of Patients Receiving the Allocated Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Pregnancy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr.Yulia Lin | Sunnybrook Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada | ||
| St. Michael's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35509085 | Background | Kron A, Del Giudice ME, Sholzberg M, Callum J, Cserti-Gazdewich C, Swarup V, Huang M, Distefano L, Anani W, Skeate R, Armali C, Lin Y. Daily versus every other day oral iron supplementation in patients with iron deficiency anemia (DEODO): study protocol for a phase 3 multicentered, pragmatic, open-label, pilot randomized controlled trial. Pilot Feasibility Stud. 2022 May 4;8(1):98. doi: 10.1186/s40814-022-01042-y. | |
| 36999886 |
| Label | URL |
|---|---|
| Final manuscript - letter to the editor | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Iron Daily | Ferrous sulfate (iron) 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks |
| FG001 | Iron Every Other Day | Ferrous sulfate (iron) 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Iron Daily | Ferrous sulfate (iron) 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks |
| BG001 | Iron Every Other Day | Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Enrolling Patients in the Trial | Enrollment in the trial will be defined as documentation of informed consent for patients approached. The primary outcome of this study is the feasibility of enrolling 52 participants in the trial over a 2-year period. Eligibility based on lab criteria was determined after consent. | Posted | Number | participants | 2 years |
|
|
Adverse event data was collected at weeks 4, 8, and 12.
Adverse events were documented at each follow-up according to the Common Terminology Criteria for Adverse Events (Version 5.0). A modified adverse effects of oral iron questionnaire was used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferrous Sulfate and Vitamin C Every Other Day | Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks Ferrous Sulfate 300Mg Tablet: oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C Vitamin C 500Mg tablet: Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment | Adverse effect reported at week 4 using adverse effect questionnaire. |
The exclusion of previously intolerant oral iron patients may bias the study group. Slight imbalances in IDA cause between daily and EOD groups may favour hemoglobin improvement in the daily group. Lack of blinding could impact patient reporting on FACIT-fatigue or adverse effects. Using oral vitamin C may now be unnecessary; recent study shows no added benefit when it is taken with oral iron. The timing of the iron indices (serum iron, transferrin saturation) was not recorded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yulia Lin | Sunnybrook Health Sciences Centre | 4164804042 | yulia.lin@sunnybrook.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2020 | May 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2020 | Oct 20, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D019189 | Iron Metabolism Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
| D013607 | Tablets |
| D007501 | Iron |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D019216 | Metals, Heavy |
| D004602 | Elements |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vitamin C 500Mg tablet | Drug | Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate |
|
|
Proportion of patients who signed informed consent and received the allocated treatment they were randomly assigned to. |
| 2 years |
| Proportion of Patients Completing Laboratory Tests | Proportion of treated patients who completed both 4 week and 12 week laboratory tests | 2 years |
| Proportion of Treated Patients Completing Side Effect Questionnaire at Week 4, 8 and 12 | Proportion of treated patients completing 4 week, 8 week and 12 week side effect questionnaire | 2 years |
| Proportion of Patients Completing FACIT-fatigue Scale | Proportion of patients who received treatment and completed 4 week, 8 week and 12 week FACIT-fatigue scale | 2 years |
| Adherence to Treatment | Adherence was measured by the proportion of treated patients who took at least 90% of their prescribed doses | 2 years |
| Proportion of Treated Patients Requiring a Step Down in Therapy | Proportion of treated patients requiring a step down in therapy by Week 4 and Week 12 (same proportions at both time points). | 2 years |
| Hemoglobin Increment | Hemoglobin increment at 4 and 12 weeks is defined as the 4 or 12 week hemoglobin value minus the baseline hemoglobin value | 12 weeks |
| Proportion With Complete Hemoglobin Response | Proportion with complete hemoglobin response defined as hemoglobin greater than or equal to 120 g/L in women; and 130 g/L in men at 4 weeks and 12 weeks | 2 years |
| Reticulocyte Count | Change in reticulocyte count at 4 and 12 weeks defined as the 4 or 12 week reticulocyte count minus the baseline reticulocyte count | 12 weeks |
| Change in Ferritin at 12 Weeks | Change in ferritin at 12 weeks, defined as the value at 12 weeks minus the baseline value. | 12 weeks |
| Change in Serum Iron at 12 Weeks | Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value | 12 weeks |
| Change in TSAT at 12 Weeks | Change in transferrin saturation (TSAT) at 12 weeks defined as the value at 12 weeks minus the baseline value. Interquartile range represents Q1 (25th percentile) to Q3 (75th percentile) | 12 weeks |
| FACIT-fatigue Score at 4, 8 and 12 Weeks | Quality of life (FACIT-fatigue scale) at 4, 8 and 12 weeks. Functional Assessment of Chronic Illness Therapy (FACIT) - fatigue scale. On this scale, lower scores indicate better symptoms and higher scores represent worse symptoms. The FACIT-fatigue scale has a range from 0 to 52. | 12 weeks |
| Proportion of Patients With Side Effects at 4, 8 and 12 Weeks | Proportion of patients with side effects at 4, 8 and 12 weeks, as determined by the oral iron side effect questionnaire | 12 weeks |
| Proportion of Patients Who Stopped Oral Iron Due to Side Effects | Number of patients who discontinued oral iron therapy due to side effects by week 12. | 12 weeks |
| Number of Patients in Need of Escalation Therapy | Need for escalation in therapy (increase in oral iron regimen from every other day to daily, need for intravenous iron, need for transfusion, visit to emergency department related to anemia) assessed at 12 weeks | 2 years |
| Proportion of Patients With a Drop in Hemoglobin at Weeks 4 and 12 | Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12 | 2 years |
| Types of Adverse Effects at 4 Weeks | Proportion of patients with each type of adverse event at week 4. | 4 Weeks |
| Toronto |
| Ontario |
| M5B 1W8 |
| Canada |
| Background |
| Lin Y, Del Giudice ME, Kron A, Meirovich H, Sholzberg M, Swarup V, Huang M, Distefano L, Anani WQ, Armali C, Bussel JB, Callum J. A pilot feasibility trial of daily versus every other day oral iron supplementation in patients with iron deficiency anaemia. Br J Haematol. 2023 Jun;201(5):1000-1004. doi: 10.1111/bjh.18792. Epub 2023 Mar 31. No abstract available. |
| Study protocol | View source |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Reason for iron deficient anemia (IDA) diagnosis | Count of Participants | Participants |
|
| History of bleeding in the past 2 months | Count of Participants | Participants |
|
| Menstrual bleeding, pictorial blood assessment chart >/= 100 | Count of Participants | Participants |
|
| History of rheumatological disorders | Count of Participants | Participants |
|
| Medication history | Count of Participants | Participants |
|
| Oral iron use in the past year | Count of Participants | Participants |
|
| IV iron use in the past year | Count of Participants | Participants |
|
| Baseline haemoglobin | Mean | Standard Deviation | g/L |
|
| Baseline haemoglobin <100 g/L | Count of Participants | Participants |
|
| Baseline mean corpuscular volume (MCV) | Mean | Standard Deviation | fL |
|
| Baseline reticulocyte count | Median | Inter-Quartile Range | x10^9 cells/L |
|
| Baseline ferritin | Median | Inter-Quartile Range | mu grams/L |
|
| Baseline serum iron | Median | Inter-Quartile Range | mu mol/L |
|
| Baseline C reactive protein | Median | Inter-Quartile Range | mg/L |
|
| Baseline C reactive protein >/=5 mg/L | Count of Participants | Participants |
|
| Baseline creatinine | Median | Inter-Quartile Range | mg/dL |
|
|
| Secondary | Proportion of Eligible Participants Consenting | Proportion of eligible patients after initial inclusion/exclusion screening that consent to participating in the study. Eligibility based on lab criteria was determined after consent. | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Proportion of Patients Receiving the Allocated Treatment | Proportion of patients who signed informed consent and received the allocated treatment they were randomly assigned to. | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Proportion of Patients Completing Laboratory Tests | Proportion of treated patients who completed both 4 week and 12 week laboratory tests | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Proportion of Treated Patients Completing Side Effect Questionnaire at Week 4, 8 and 12 | Proportion of treated patients completing 4 week, 8 week and 12 week side effect questionnaire | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Proportion of Patients Completing FACIT-fatigue Scale | Proportion of patients who received treatment and completed 4 week, 8 week and 12 week FACIT-fatigue scale | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Adherence to Treatment | Adherence was measured by the proportion of treated patients who took at least 90% of their prescribed doses | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Proportion of Treated Patients Requiring a Step Down in Therapy | Proportion of treated patients requiring a step down in therapy by Week 4 and Week 12 (same proportions at both time points). | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Hemoglobin Increment | Hemoglobin increment at 4 and 12 weeks is defined as the 4 or 12 week hemoglobin value minus the baseline hemoglobin value | Posted | Mean | Standard Deviation | g/L | 12 weeks |
|
|
|
| Secondary | Proportion With Complete Hemoglobin Response | Proportion with complete hemoglobin response defined as hemoglobin greater than or equal to 120 g/L in women; and 130 g/L in men at 4 weeks and 12 weeks | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Reticulocyte Count | Change in reticulocyte count at 4 and 12 weeks defined as the 4 or 12 week reticulocyte count minus the baseline reticulocyte count | Posted | Median | Inter-Quartile Range | x10^9 cells/ L | 12 weeks |
|
|
|
| Secondary | Change in Ferritin at 12 Weeks | Change in ferritin at 12 weeks, defined as the value at 12 weeks minus the baseline value. | Posted | Median | Inter-Quartile Range | mcg/L | 12 weeks |
|
|
|
| Secondary | Change in Serum Iron at 12 Weeks | Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value | Posted | Median | Inter-Quartile Range | micro mol/L | 12 weeks |
|
|
|
| Secondary | Change in TSAT at 12 Weeks | Change in transferrin saturation (TSAT) at 12 weeks defined as the value at 12 weeks minus the baseline value. Interquartile range represents Q1 (25th percentile) to Q3 (75th percentile) | Posted | Median | Inter-Quartile Range | percentile | 12 weeks |
|
|
|
| Secondary | FACIT-fatigue Score at 4, 8 and 12 Weeks | Quality of life (FACIT-fatigue scale) at 4, 8 and 12 weeks. Functional Assessment of Chronic Illness Therapy (FACIT) - fatigue scale. On this scale, lower scores indicate better symptoms and higher scores represent worse symptoms. The FACIT-fatigue scale has a range from 0 to 52. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Proportion of Patients With Side Effects at 4, 8 and 12 Weeks | Proportion of patients with side effects at 4, 8 and 12 weeks, as determined by the oral iron side effect questionnaire | Posted | Number | Proportion of participants | 12 weeks |
|
|
|
| Secondary | Proportion of Patients Who Stopped Oral Iron Due to Side Effects | Number of patients who discontinued oral iron therapy due to side effects by week 12. | Posted | Number | Proportion of participants | 12 weeks |
|
|
|
| Secondary | Number of Patients in Need of Escalation Therapy | Need for escalation in therapy (increase in oral iron regimen from every other day to daily, need for intravenous iron, need for transfusion, visit to emergency department related to anemia) assessed at 12 weeks | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Proportion of Patients With a Drop in Hemoglobin at Weeks 4 and 12 | Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12 | Posted | Number | Proportion of participants | 2 years |
|
|
|
| Secondary | Types of Adverse Effects at 4 Weeks | Proportion of patients with each type of adverse event at week 4. | Posted | Number | Proportion of participants | 4 Weeks |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 15 |
| 27 |
| EG001 | Ferrous Sulfate and Vitamin C Daily | Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks Ferrous Sulfate 300Mg Tablet: oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C Vitamin C 500Mg tablet: Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate | 0 | 24 | 0 | 24 | 9 | 24 |
| EG002 | Total/All Participants | Overall proportion of patients with adverse effects. | 0 | 51 | 0 | 51 | 24 | 51 |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Adverse effect reported at week 4 using questionnaire |
|
| Headache | Nervous system disorders | Systematic Assessment | Adverse effect reported at Week 4 using questionnaire |
|
| Breathlessness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse effect reported at week 4 using questionnaire |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment | Adverse effect reported at week 4 using questionnaire |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Adverse effect reported at week 4 using questionnaire |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Adverse effect reported at week 4 using questionnaire |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Adverse effect reported at week 4 using questionnaire |
|
Not provided
Not provided
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007287 |
| Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| Gastrointestinal |
|
| Other |
|
|
| Hemoglobin at 12 weeks |
|
|
| Week 12 reticulocyte count |
|
|
|
|
|
| Week 12 FACIT-fatigue score |
|
| Title | Measurements |
|---|---|
|
| Week 12 |
|
| Title | Measurements |
|---|---|
|
| Headache |
|
| Breathlessness |
|
| Heartburn |
|
| Abdominal pain |
|
| Diarrhea |
|
| Vomiting |
|
| Other |
|