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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: St. Michael's Hospital, Toronto; Unity Health Toronto
• Treatments: Ascorbic Acid; Iron; Vitamins

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)