Clinical trial NCT03725384: Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency Anemia
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Iron Deficiency Anemia
Keywords: Anemia
Iron deficiency
hemoglobin
oral iron
Ferrous sulfate
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2018-10-31
Enrollment: 51
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of Enrolling Patients in the Trial
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of Eligible Participants Consenting
timeFrame: 2 years
measure: Proportion of Patients Receiving the Allocated Treatment
timeFrame: 2 years
measure: Proportion of Patients Completing Laboratory Tests
timeFrame: 2 years
measure: Proportion of Treated Patients Completing Side Effect Questionnaire at Week 4, 8 and 12
timeFrame: 2 years
measure: Proportion of Patients Completing FACIT-fatigue Scale
timeFrame: 2 years
measure: Adherence to Treatment
timeFrame: 2 years
measure: Proportion of Treated Patients Requiring a Step Down in Therapy
timeFrame: 2 years
measure: Hemoglobin Increment
timeFrame: 12 weeks
measure: Proportion With Complete Hemoglobin Response
timeFrame: 2 years
measure: Reticulocyte Count
timeFrame: 12 weeks
measure: Change in Ferritin at 12 Weeks
timeFrame: 12 weeks
measure: Change in Serum Iron at 12 Weeks
timeFrame: 12 weeks
measure: Change in TSAT at 12 Weeks
timeFrame: 12 weeks
measure: FACIT-fatigue Score at 4, 8 and 12 Weeks
timeFrame: 12 weeks
measure: Proportion of Patients With Side Effects at 4, 8 and 12 Weeks
timeFrame: 12 weeks
measure: Proportion of Patients Who Stopped Oral Iron Due to Side Effects
timeFrame: 12 weeks
measure: Number of Patients in Need of Escalation Therapy
timeFrame: 2 years
measure: Proportion of Patients With a Drop in Hemoglobin at Weeks 4 and 12
timeFrame: 2 years
measure: Types of Adverse Effects at 4 Weeks
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Center
name: Dr.Yulia Lin
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.