Phase 3 N=51 Randomized Treatment

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

Anemia · Iron Deficiency Anemia

Bottom Line

View on ClinicalTrials.gov: NCT03725384 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Feasibility of Enrolling Patients in the Trial — 85 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ferrous Sulfate 300Mg Tablet (Drug); Vitamin C 500Mg tablet (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Sunnybrook Health Sciences Centre
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Enrolling Patients in the Trial	85	—
SECONDARY Proportion of Eligible Participants Consenting	0.39	—
SECONDARY Proportion of Patients Receiving the Allocated Treatment	0.96; 1; 0.98	—
SECONDARY Proportion of Patients Completing Laboratory Tests	0.91; 0.81; 0.86	—
SECONDARY Proportion of Treated Patients Completing Side Effect Questionnaire at Week 4, 8 and 12	0.91; 0.85	—
SECONDARY Proportion of Patients Completing FACIT-fatigue Scale	0.91; 0.89	—
SECONDARY Adherence to Treatment	0.78; 0.82	—
SECONDARY Proportion of Treated Patients Requiring a Step Down in Therapy	0.13; 0	—
SECONDARY Hemoglobin Increment	110; 110; 110; 122; 119; 121	—
SECONDARY Proportion With Complete Hemoglobin Response	0.59; 0.75	—
SECONDARY Reticulocyte Count	48; 47; 48; 61; 65; 64	—
SECONDARY Change in Ferritin at 12 Weeks	9; 9; 9; 30; 23; 27	—
SECONDARY Change in Serum Iron at 12 Weeks	8; 5; 7; 17; 12; 16	—
SECONDARY Change in TSAT at 12 Weeks	11; 7; 9; 26; 18; 23	—
SECONDARY FACIT-fatigue Score at 4, 8 and 12 Weeks	23.9; 26.3; 25.2; 21.5; 24.9; 23.4	—
SECONDARY Proportion of Patients With Side Effects at 4, 8 and 12 Weeks	0.38; 0.56; 0.47; 0.33; 0.48; 0.41	—
SECONDARY Proportion of Patients Who Stopped Oral Iron Due to Side Effects	0; 0; 0	—
SECONDARY Number of Patients in Need of Escalation Therapy	0; 0	—
SECONDARY Proportion of Patients With a Drop in Hemoglobin at Weeks 4 and 12	0; 0	—
SECONDARY Types of Adverse Effects at 4 Weeks	0.25; 0.22; 0.24; 0.17; 0.26; 0.22	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03725384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.