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

NCT03725384 | Completed Phase 3 Results

• 1 other identifier: CTO ID 1534
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Anemia; Iron Deficiency Anemia

Keywords

Anemia; Iron deficiency; hemoglobin; oral iron; Ferrous sulfate

Outcome Measures

Primary Outcomes (1)

• Feasibility of Enrolling Patients in the Trial

  Enrollment in the trial will be defined as documentation of informed consent for patients approached. The primary outcome of this study is the feasibility of enrolling 52 participants in the trial over a 2-year period. Eligibility based on lab criteria was determined after consent.

  2 years

Secondary Outcomes (19)

• Proportion of Eligible Participants Consenting

  2 years

• Proportion of Patients Receiving the Allocated Treatment

  2 years

• Proportion of Patients Completing Laboratory Tests

  2 years

• Proportion of Treated Patients Completing Side Effect Questionnaire at Week 4, 8 and 12

  2 years

• Proportion of Patients Completing FACIT-fatigue Scale

  2 years

Study Arms (2)

Ferrous Sulfate and Vitamin C every other day

EXPERIMENTAL

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

Drug: Ferrous Sulfate 300Mg Tablet; Drug: Vitamin C 500Mg tablet

Ferrous Sulfate and Vitamin C daily

ACTIVE COMPARATOR

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

Drug: Ferrous Sulfate 300Mg Tablet; Drug: Vitamin C 500Mg tablet

Interventions

Ferrous Sulfate 300Mg Tablet DRUG

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

Also known as: Iron, Oral iron

Ferrous Sulfate and Vitamin C daily; Ferrous Sulfate and Vitamin C every other day

Vitamin C 500Mg tablet DRUG

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

Also known as: Ascorbic acid

Ferrous Sulfate and Vitamin C daily; Ferrous Sulfate and Vitamin C every other day

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Unity Health Toronto: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (2)

• 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.

  PMID: 35509085 BACKGROUND

• 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.

  PMID: 36999886 BACKGROUND

Related Links

• Final manuscript - letter to the editor
• Study protocol

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferrous sulfate; Tablets; Iron; Ascorbic Acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Limitations and Caveats

The exclusion of previously intolerant oral iron patients may bias the study group. Slight imbalances in IDA cause between daily and EOD groups may favour hemoglobin improvement in the daily group. Lack of blinding could impact patient reporting on FACIT-fatigue or adverse effects. Using oral vitamin C may now be unnecessary; recent study shows no added benefit when it is taken with oral iron. The timing of the iron indices (serum iron, transferrin saturation) was not recorded.

Results Point of Contact

• Title: Dr. Yulia Lin
• Organization: Sunnybrook Health Sciences Centre

yulia.lin@sunnybrook.ca

4164804042

Study Officials

• Dr.Yulia Lin

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 31, 2018
• Study Start: January 4, 2019
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2024-05

Locations

CA (2)