Iron Deficiency AnemiaPhase 3NCT04130828
Thrice-weekly Versus Thrice-daily Oral Ferrous Fumarate Treatment in Adult Patients With Iron Deficiency Anemia
A Phase 3 study testing Ferrous Fumarate in people with Iron Deficiency Anemia, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. Patients with iron deficiency and Iron deficiency anemia can present with a multitude of symptoms including fatigue, dyspnea on exertion, dysphagia, pallor, palpitations, headaches, tinnitus, taste disturbance and pica. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferrous Fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteThailand
- Study dates
- 21 Jan 2020to 18 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Patients with iron deficiency anemia defined as hemoglobin less than 12 g/dL in women or 13 g/dL in men; AND ferritin less than 30 ng/mL
Who cannot join
- Allergy to iron
- Currently pregnancy
- Currently breastfeeding
- Known history of inflammatory bowel disease, celiac disease, inherited bleeding disorder, solid cancer, hematologic cancer or thalassemia
- Renal impairment or glomerular filtration rate less than 30 ml/min/1.73m2
- Hepatic impairment or Child Pugh score more than 7
Show all 15Show fewer
- Active bleeding define hemoglobin decrease more than 2 g/dL
- Multivitamin and mineral supplement (35 mg or more of elemental iron per day) in 2 weeks prior to randomization
- Non-literate
- Subject withdrawal criteria:
- Intolerance to drugs
- Active bleeding define hemoglobin decrease more than 2 g/dL
- Major surgery
- Blood transfusion
- Loss follow-up more than 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. Patients with iron deficiency and Iron deficiency anemia can present with a multitude of symptoms including fatigue, dyspnea on exertion, dysphagia, pallor, palpitations, headaches, tinnitus, taste disturbance 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
- Iron Deficiency Anemia
- Being tested
- Ferrous Fumarate
- Keywords
- ferrous fumarate, oral iron treatment, thrice-weekly, thrice-daily, iron deficiency anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous FumarateDrug
Ferrous fumarate 200 mg PO PC
| Study group | Role | What they receive |
|---|---|---|
| Thrice-weekly group | Experimental | Ferrous fumarate 200 mg PO PC Thrice-weekly Receives: Drug: Ferrous Fumarate |
| Thrice-daily group | Active comparator | Ferrous fumarate 200 mg PO PC Thrice-daily Receives: Drug: Ferrous Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient who achieved hemoglobin target
Hemoglobin achieved 12 g/dL in women, 13 g/dL in men and or increased 1g/dL/4weeks
Measured: 12 weeks
Secondary outcomes (1)
Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start21 Jan 2020
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Collaborators
- The Thai Society of Hematology
- Responsible party
- Principal investigator, Siddhibhong Jongkraijakra, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130828
- Sponsor's protocol ID
- REC.62-404-14-1
- Status last verified
- Feb 2022
- First submitted
- 16 Oct 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrice-weekly Versus Thrice-daily Oral Ferrous Fumarate Treatment in Adult Patients With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT04130828
- Acronym / sponsor ID
- REC.62-404-14-1
- Conditions
- Iron Deficiency Anemia
- Keywords
- ferrous fumarate, oral iron treatment, thrice-weekly, thrice-daily, iron deficiency anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Collaborators
- The Thai Society of Hematology
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. Patients with iron deficiency and Iron deficiency anemia can present with a multitude of symptoms including fatigue, dyspnea on exertion, dysphagia, pallor, palpitations, headaches, tinnitus, taste disturbance 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrice-weekly group | Experimental | Drug: Ferrous FumarateFerrous fumarate 200 mg PO PC Thrice-weekly |
| Thrice-daily group | Active comparator | Drug: Ferrous FumarateFerrous fumarate 200 mg PO PC Thrice-daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Patients with iron deficiency anemia defined as hemoglobin less than 12 g/dL in women or 13 g/dL in men; AND ferritin less than 30 ng/mL
Key exclusion criteria (15 listed)
- Allergy to iron
- Currently pregnancy
- Currently breastfeeding
- Known history of inflammatory bowel disease, celiac disease, inherited bleeding disorder, solid cancer, hematologic cancer or thalassemia
- Renal impairment or glomerular filtration rate less than 30 ml/min/1.73m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous FumarateFerrous fumarate 200 mg PO PC | Drug | Thrice-daily group, Thrice-weekly group |
Primary outcome
Proportion of patient who achieved hemoglobin target
Time frame: 12 weeks
Hemoglobin achieved 12 g/dL in women, 13 g/dL in men and or increased 1g/dL/4weeks
1 secondary outcome
Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferrous Fumarate in people with Iron Deficiency Anemia, run by Prince of Songkla University at 1 site in Thailand.
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 15 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patient who achieved hemoglobin target (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2022.