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

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia; Anemia

Treatments: Drug: Vitamin C 500Mg tablet; Drug: Ferrous Sulfate 300Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03725384

CTO ID 1534

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Ferrous Sulfate and Vitamin C every other day

Experimental group

Description:

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

Treatment:

Drug: Ferrous Sulfate 300Mg Tablet

Drug: Vitamin C 500Mg tablet

Ferrous Sulfate and Vitamin C daily

Active Comparator group

Description:

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

Treatment:

Drug: Ferrous Sulfate 300Mg Tablet

Drug: Vitamin C 500Mg tablet