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

Anemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725384
• Other study ID #: CTO ID 1534
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2019
• Est. completion date: January 26, 2022

Study information

• Verified date: May 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 26, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	Enrollment in the trial will be defined as documentation of informed consent for patients approached	2 years
Secondary	Proportion of eligible participants consenting to participate	Proportion of eligible patients consenting to participate	2 years
Secondary	Proportion of consenting patients receiving the allocated treatment	Proportion of consenting patients receiving the allocated treatment	2 years
Secondary	Treated patients completing 4 and 12 week laboratory tests	Proportion of treated patients completing 4 week and 12 week laboratory tests	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	2 years
Secondary	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	2 years
Secondary	Proportion of treatment doses taken per protocol based on pill count	Proportion of treatment doses taken as per protocol based on pill count	12 weeks
Secondary	Proportion of treated patients taking 90% of prescribed doses	Proportion of treated patients taking at least 90% of their prescribed doses	2 years
Secondary	Proportion of treated patients requiring a step down in therapy	Proportion of treated patients requiring a step down in therapy	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	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	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	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	12 weeks
Secondary	FACIT-fatigue scale at 4, 8 and 12 weeks	Quality of life (FACIT-fatigue scale) at 4, 8 and 12 weeks	12 weeks
Secondary	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	12 weeks
Secondary	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	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	2 years
Secondary	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	2 years