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AnemiaPhase 3DEODONCT03725384

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

A Phase 3 study testing Ferrous Sulfate 300Mg Tablet and Vitamin C 500Mg tablet in people with Anemia and Iron Deficiency Anemia, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Anemia, Iron Deficiency Anemia
What is being tested?
Ferrous Sulfate 300Mg Tablet and Vitamin C 500Mg tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
2 sitesCanada
Study dates
4 Jan 2019to 26 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • • 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
Show all 19Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Ferrous Sulfate 300Mg Tablet, Vitamin C 500Mg tablet
Keywords
Anemia, Iron deficiency, hemoglobin, oral iron, Ferrous sulfate
Medical subject headings
Anemia, Anemia, Iron-Deficiency, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferrous Sulfate 300Mg TabletDrug

    Also called Iron, Oral iron

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

  • Vitamin C 500Mg tabletDrug

    Also called Ascorbic acid

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

Study groups in NCT03725384
Study groupRoleWhat they receive
Ferrous Sulfate and Vitamin C every other dayExperimentalFerrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks
Receives: Drug: Ferrous Sulfate 300Mg Tablet; Drug: Vitamin C 500Mg tablet
Ferrous Sulfate and Vitamin C dailyActive comparatorFerrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks
Receives: Drug: Ferrous Sulfate 300Mg Tablet; Drug: Vitamin C 500Mg tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (19)

  1. Proportion of Eligible Participants Consenting

    Proportion of eligible patients after initial inclusion/exclusion screening that consent to participating in the study. Eligibility based on lab criteria was determined after consent.

    Measured: 2 years

  2. Proportion of Patients Receiving the Allocated Treatment

    Proportion of patients who signed informed consent and received the allocated treatment they were randomly assigned to.

    Measured: 2 years

  3. Proportion of Patients Completing Laboratory Tests

    Proportion of treated patients who completed both 4 week and 12 week laboratory tests

    Measured: 2 years

  4. 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

    Measured: 2 years

  5. Proportion of Patients Completing FACIT-fatigue Scale

    Proportion of patients who received treatment and completed 4 week, 8 week and 12 week FACIT-fatigue scale

    Measured: 2 years

  6. Adherence to Treatment

    Adherence was measured by the proportion of treated patients who took at least 90% of their prescribed doses

    Measured: 2 years

  7. Proportion of Treated Patients Requiring a Step Down in Therapy

    Proportion of treated patients requiring a step down in therapy by Week 4 and Week 12 (same proportions at both time points).

    Measured: 2 years

  8. Hemoglobin Increment

    Hemoglobin increment at 4 and 12 weeks is defined as the 4 or 12 week hemoglobin value minus the baseline hemoglobin value

    Measured: 12 weeks

  9. 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

    Measured: 2 years

  10. 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

    Measured: 12 weeks

  11. Change in Ferritin at 12 Weeks

    Change in ferritin at 12 weeks, defined as the value at 12 weeks minus the baseline value.

    Measured: 12 weeks

  12. Change in Serum Iron at 12 Weeks

    Change in serum iron at 12 weeks defined as the value at 12 weeks minus the baseline value

    Measured: 12 weeks

  13. Change in TSAT at 12 Weeks

    Change in transferrin saturation (TSAT) at 12 weeks defined as the value at 12 weeks minus the baseline value. Interquartile range represents Q1 (25th percentile) to Q3 (75th percentile)

    Measured: 12 weeks

  14. FACIT-fatigue Score at 4, 8 and 12 Weeks

    Quality of life (FACIT-fatigue scale) at 4, 8 and 12 weeks. Functional Assessment of Chronic Illness Therapy (FACIT) - fatigue scale.

    On this scale, lower scores indicate better symptoms and higher scores represent worse symptoms. The FACIT-fatigue scale has a range from 0 to 52.

    Measured: 12 weeks

  15. Proportion of Patients With Side Effects at 4, 8 and 12 Weeks

    Proportion of patients with side effects at 4, 8 and 12 weeks, as determined by the oral iron side effect questionnaire

    Measured: 12 weeks

  16. Proportion of Patients Who Stopped Oral Iron Due to Side Effects

    Number of patients who discontinued oral iron therapy due to side effects by week 12.

    Measured: 12 weeks

  17. 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

    Measured: 2 years

  18. Proportion of Patients With a Drop in Hemoglobin at Weeks 4 and 12

    Proportion of patients with a drop in hemoglobin of 10 g/L or more at weeks 4 and 12

    Measured: 2 years

  19. Types of Adverse Effects at 4 Weeks

    Proportion of patients with each type of adverse event at week 4.

    Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2018
  2. Study start4 Jan 2019
  3. Primary completion26 Jan 2022
  4. Study completion26 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03725384
Sponsor's protocol ID
CTO ID 1534
Acronym
DEODO
Status last verified
May 2024
First submitted
23 Oct 2018
Last updated
3 Feb 2025
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35509085

  • 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.

    PubMed 36999886

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferrous Sulfate 300Mg Tablet and Vitamin C 500Mg tablet in people with Anemia and Iron Deficiency Anemia, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Enrolling Patients in the Trial (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03725384, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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