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

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ClinicalTrials.gov Identifier: NCT03725384
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
Unity Health Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Anemia Iron Deficiency Anemia Drug: Ferrous Sulfate 300Mg Tablet Drug: Vitamin C 500Mg tablet Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: 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
Drug: Ferrous Sulfate 300Mg Tablet
oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C
Other Names:
  • Iron
  • Oral iron

Drug: Vitamin C 500Mg tablet
Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate
Other Name: Ascorbic acid

Active Comparator: Ferrous Sulfate and Vitamin C daily
Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks
Drug: Ferrous Sulfate 300Mg Tablet
oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C
Other Names:
  • Iron
  • Oral iron

Drug: Vitamin C 500Mg tablet
Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate
Other Name: Ascorbic acid




Primary Outcome Measures :
  1. Enrollment [ Time Frame: 2 years ]
    Enrollment in the trial will be defined as documentation of informed consent for patients approached


Secondary Outcome Measures :
  1. Proportion of eligible participants consenting to participate [ Time Frame: 2 years ]
    Proportion of eligible patients consenting to participate

  2. Proportion of consenting patients receiving the allocated treatment [ Time Frame: 2 years ]
    Proportion of consenting patients receiving the allocated treatment

  3. Treated patients completing 4 and 12 week laboratory tests [ Time Frame: 2 years ]
    Proportion of treated patients completing 4 week and 12 week laboratory tests

  4. Proportion of treated patients completing side effect questionnaire at week 4, 8 and 12 [ Time Frame: 2 years ]
    Proportion of treated patients completing 4 week, 8 week and 12 week side effect questionnaire

  5. Proportion of treated patients completing 4 week, 8 week and 12 week FACIT-fatigue scale [ Time Frame: 2 years ]
    Proportion of treated patients completing 4 week, 8 week and 12 week FACIT-fatigue scale

  6. Proportion of treatment doses taken per protocol based on pill count [ Time Frame: 12 weeks ]
    Proportion of treatment doses taken as per protocol based on pill count

  7. Proportion of treated patients taking 90% of prescribed doses [ Time Frame: 2 years ]
    Proportion of treated patients taking at least 90% of their prescribed doses

  8. Proportion of treated patients requiring a step down in therapy [ Time Frame: 2 years ]
    Proportion of treated patients requiring a step down in therapy

  9. Hemoglobin increment [ Time Frame: 12 weeks ]
    Hemoglobin increment at 4 and 12 weeks is defined as the 4 or 12 week hemoglobin value minus the baseline hemoglobin value

  10. Proportion with complete hemoglobin response [ Time Frame: 2 years ]
    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

  11. Reticulocyte count [ Time Frame: 12 weeks ]
    Change in reticulocyte count at 4 and 12 weeks defined as the 4 or 12 week reticulocyte count minus the baseline reticulocyte count

  12. Change in ferritin, at 12 weeks defined as the value at 12 weeks minus the baseline value [ Time Frame: 12 weeks ]
    Change in ferritin, at 12 weeks defined as the value at 12 weeks minus the baseline value

  13. Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value [ Time Frame: 12 weeks ]
    Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value

  14. Change in TSAT at 12 weeks defined as the value at 12 weeks minus the baseline value [ Time Frame: 12 weeks ]
    Change in TSAT at 12 weeks defined as the value at 12 weeks minus the baseline value

  15. FACIT-fatigue scale at 4, 8 and 12 weeks [ Time Frame: 12 weeks ]
    Quality of life (FACIT-fatigue scale) at 4, 8 and 12 weeks

  16. 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 ]
    Proportion with side effects and type of side effects at 4, 8 and 12 weeks as determined by the oral iron side effect questionnaire

  17. Proportion of patients who stop taking oral iron due to side effects at 4 and 12 weeks [ Time Frame: 12 weeks ]
    Proportion of patients who stop taking oral iron due to side effects at 4 and 12 weeks

  18. Number of patients in need of escalation therapy [ Time Frame: 2 years ]
    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

  19. Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12 [ Time Frame: 2 years ]
    Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725384


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Amie Kron    416-480-6100 ext 85178    amie.kron@sunnybrook.ca   
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Vidushi Swarup    416-864-6060 ext 2408    vidushi.swarup@unityhealth.to   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Unity Health Toronto
Investigators
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Principal Investigator: Dr.Yulia Lin Sunnybrook Health Sciences Center
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03725384    
Other Study ID Numbers: CTO ID 1534
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Anemia
Iron deficiency
hemoglobin
oral iron
Ferrous sulfate
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Ascorbic Acid
Iron
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents