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

NCT ID: NCT03725384

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2022-01-26

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.

Conditions

Anemia; Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferrous Sulfate and Vitamin C every other day

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

Group Type: EXPERIMENTAL

Ferrous Sulfate 300Mg Tablet

Intervention Type: DRUG

oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C

Vitamin C 500Mg tablet

Intervention Type: DRUG

Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate

Ferrous Sulfate and Vitamin C daily

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

Group Type: ACTIVE_COMPARATOR

Ferrous Sulfate 300Mg Tablet

Intervention Type: DRUG

oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C

Vitamin C 500Mg tablet

Intervention Type: DRUG

Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate

Interventions

Ferrous Sulfate 300Mg Tablet

oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C

Intervention Type: DRUG

Vitamin C 500Mg tablet

Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate

Intervention Type: DRUG

Other Intervention Names

Iron; Oral iron; Ascorbic acid

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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr.Yulia Lin

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 35509085 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36999886 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/36999886/

Final manuscript - letter to the editor

https://pubmed.ncbi.nlm.nih.gov/35509085/

Study protocol

Other Identifiers

CTO ID 1534

Identifier Type: -

Identifier Source: org_study_id