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Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency Anemia (DEODO)

Primary Purpose

Anemia, Iron Deficiency Anemia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Ferrous Sulfate 300Mg Tablet
Vitamin C 500Mg tablet
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Iron deficiency, hemoglobin, oral iron, Ferrous sulfate

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 16 years;
  • Outpatients with iron deficiency anemia defined as Hb less than 120 g/L in women or 130g/L in men; AND ferritin less than 30 mcg/L

Exclusion Criteria:

  • • Pregnancy

    • Currently breastfeeding
    • Known history of inflammatory bowel disease
    • Known history of celiac disease
    • Known history of thalassemia or thalassemia trait
    • Known inherited bleeding disorder
    • Known intolerance or lack of response to oral ferrous gluconate, sulfate or fumarate in the last 12 weeks
    • Multivitamin and mineral supplements (35 mg or more of elemental iron per day) in the 2 weeks prior to randomization
    • Allergy to oral iron
    • Allergy to any of the following medicinal and non-medicinal ingredients in ferrous sulfate: ferrous sulphate, calcium citrate, crospovidone, FD&C Red #40-Aluminum lake, FD&C Yellow #6-Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, purified water, talc titanium dioxide
    • Allergy to any of the following medicinal and non-medicinal ingredients in vitamin C: Ascorbic acid, Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid
    • Intravenous iron therapy in the past 12 weeks
    • On anticoagulant therapy (e.g. warfarin, apixaban, dabigatran, edoxaban, rivaroxaban) initiated in the past 6 months
    • Surgery planned in upcoming 12 weeks
    • Chemotherapy planned in upcoming 12 weeks
    • Blood donation planned in upcoming 12 weeks
    • Previously enrolled in the study
    • Creatinine clearance less than 30 mL/min
    • Hemoglobin less than 80 g/L with active bleeding (defined as WHO grade 2 bleeding or higher in the past week)

Sites / Locations

  • Sunnybrook Health Sciences Centre
  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferrous Sulfate and Vitamin C every other day

Ferrous Sulfate and Vitamin C daily

Arm Description

Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks

Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks

Outcomes

Primary Outcome Measures

Enrollment
Enrollment in the trial will be defined as documentation of informed consent for patients approached

Secondary Outcome Measures

Proportion of eligible participants consenting to participate
Proportion of eligible patients consenting to participate
Proportion of consenting patients receiving the allocated treatment
Proportion of consenting patients receiving the allocated treatment
Treated patients completing 4 and 12 week laboratory tests
Proportion of treated patients completing 4 week and 12 week laboratory tests
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
Proportion of treated patients completing 4 week, 8 week and 12 week FACIT-fatigue scale
Proportion of treated patients completing 4 week, 8 week and 12 week FACIT-fatigue scale
Proportion of treatment doses taken per protocol based on pill count
Proportion of treatment doses taken as per protocol based on pill count
Proportion of treated patients taking 90% of prescribed doses
Proportion of treated patients taking at least 90% of their prescribed doses
Proportion of treated patients requiring a step down in therapy
Proportion of treated patients requiring a step down in therapy
Hemoglobin increment
Hemoglobin increment at 4 and 12 weeks is defined as the 4 or 12 week hemoglobin value minus the baseline hemoglobin value
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
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
Change in ferritin, at 12 weeks defined as the value at 12 weeks minus the baseline value
Change in ferritin, at 12 weeks defined as the value at 12 weeks minus the baseline value
Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value
Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value
Change in TSAT at 12 weeks defined as the value at 12 weeks minus the baseline value
Change in TSAT at 12 weeks defined as the value at 12 weeks minus the baseline value
FACIT-fatigue scale at 4, 8 and 12 weeks
Quality of life (FACIT-fatigue scale) at 4, 8 and 12 weeks
Proportion with side effects and type of side effects at 4, 8 and 12 weeks as determined by the oral iron side effect questionnaire
Proportion with side effects and type of side effects at 4, 8 and 12 weeks as determined by the oral iron side effect questionnaire
Proportion of patients who stop taking oral iron due to side effects at 4 and 12 weeks
Proportion of patients who stop taking oral iron due to side effects at 4 and 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
Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12
Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12

Full Information

First Posted
October 23, 2018
Last Updated
May 4, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03725384
Brief Title
Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency Anemia
Acronym
DEODO
Official Title
Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency Anemia (DEODO): a Multi-centered, Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
January 26, 2022 (Actual)
Study Completion Date
January 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency Anemia
Keywords
Anemia, Iron deficiency, hemoglobin, oral iron, Ferrous sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferrous Sulfate and Vitamin C every other day
Arm Type
Experimental
Arm Description
Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks
Arm Title
Ferrous Sulfate and Vitamin C daily
Arm Type
Active Comparator
Arm Description
Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate 300Mg Tablet
Other Intervention Name(s)
Iron, Oral iron
Intervention Description
oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C
Intervention Type
Drug
Intervention Name(s)
Vitamin C 500Mg tablet
Other Intervention Name(s)
Ascorbic acid
Intervention Description
Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate
Primary Outcome Measure Information:
Title
Enrollment
Description
Enrollment in the trial will be defined as documentation of informed consent for patients approached
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Proportion of eligible participants consenting to participate
Description
Proportion of eligible patients consenting to participate
Time Frame
2 years
Title
Proportion of consenting patients receiving the allocated treatment
Description
Proportion of consenting patients receiving the allocated treatment
Time Frame
2 years
Title
Treated patients completing 4 and 12 week laboratory tests
Description
Proportion of treated patients completing 4 week and 12 week laboratory tests
Time Frame
2 years
Title
Proportion of treated patients completing side effect questionnaire at week 4, 8 and 12
Description
Proportion of treated patients completing 4 week, 8 week and 12 week side effect questionnaire
Time Frame
2 years
Title
Proportion of treated patients completing 4 week, 8 week and 12 week FACIT-fatigue scale
Description
Proportion of treated patients completing 4 week, 8 week and 12 week FACIT-fatigue scale
Time Frame
2 years
Title
Proportion of treatment doses taken per protocol based on pill count
Description
Proportion of treatment doses taken as per protocol based on pill count
Time Frame
12 weeks
Title
Proportion of treated patients taking 90% of prescribed doses
Description
Proportion of treated patients taking at least 90% of their prescribed doses
Time Frame
2 years
Title
Proportion of treated patients requiring a step down in therapy
Description
Proportion of treated patients requiring a step down in therapy
Time Frame
2 years
Title
Hemoglobin increment
Description
Hemoglobin increment at 4 and 12 weeks is defined as the 4 or 12 week hemoglobin value minus the baseline hemoglobin value
Time Frame
12 weeks
Title
Proportion with complete hemoglobin response
Description
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
Time Frame
2 years
Title
Reticulocyte count
Description
Change in reticulocyte count at 4 and 12 weeks defined as the 4 or 12 week reticulocyte count minus the baseline reticulocyte count
Time Frame
12 weeks
Title
Change in ferritin, at 12 weeks defined as the value at 12 weeks minus the baseline value
Description
Change in ferritin, at 12 weeks defined as the value at 12 weeks minus the baseline value
Time Frame
12 weeks
Title
Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value
Description
Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value
Time Frame
12 weeks
Title
Change in TSAT at 12 weeks defined as the value at 12 weeks minus the baseline value
Description
Change in TSAT at 12 weeks defined as the value at 12 weeks minus the baseline value
Time Frame
12 weeks
Title
FACIT-fatigue scale at 4, 8 and 12 weeks
Description
Quality of life (FACIT-fatigue scale) at 4, 8 and 12 weeks
Time Frame
12 weeks
Title
Proportion with side effects and type of side effects at 4, 8 and 12 weeks as determined by the oral iron side effect questionnaire
Description
Proportion with side effects and type of side effects at 4, 8 and 12 weeks as determined by the oral iron side effect questionnaire
Time Frame
12 weeks
Title
Proportion of patients who stop taking oral iron due to side effects at 4 and 12 weeks
Description
Proportion of patients who stop taking oral iron due to side effects at 4 and 12 weeks
Time Frame
12 weeks
Title
Number of patients in need of escalation therapy
Description
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
Time Frame
2 years
Title
Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12
Description
Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 16 years; Outpatients with iron deficiency anemia defined as Hb less than 120 g/L in women or 130g/L in men; AND ferritin less than 30 mcg/L Exclusion Criteria: • Pregnancy Currently breastfeeding Known history of inflammatory bowel disease Known history of celiac disease Known history of thalassemia or thalassemia trait Known inherited bleeding disorder Known intolerance or lack of response to oral ferrous gluconate, sulfate or fumarate in the last 12 weeks Multivitamin and mineral supplements (35 mg or more of elemental iron per day) in the 2 weeks prior to randomization Allergy to oral iron Allergy to any of the following medicinal and non-medicinal ingredients in ferrous sulfate: ferrous sulphate, calcium citrate, crospovidone, FD&C Red #40-Aluminum lake, FD&C Yellow #6-Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, purified water, talc titanium dioxide Allergy to any of the following medicinal and non-medicinal ingredients in vitamin C: Ascorbic acid, Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid Intravenous iron therapy in the past 12 weeks On anticoagulant therapy (e.g. warfarin, apixaban, dabigatran, edoxaban, rivaroxaban) initiated in the past 6 months Surgery planned in upcoming 12 weeks Chemotherapy planned in upcoming 12 weeks Blood donation planned in upcoming 12 weeks Previously enrolled in the study Creatinine clearance less than 30 mL/min Hemoglobin less than 80 g/L with active bleeding (defined as WHO grade 2 bleeding or higher in the past week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Yulia Lin
Organizational Affiliation
Sunnybrook Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35509085
Citation
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.
Results Reference
derived

Learn more about this trial

Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency Anemia

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