Iron Deficiency AnemiaPhase 4NCT07391371
Alternate-day Versus Daily Oral Iron Therapy in Children With Iron Deficiency Anaemia
A Phase 4 study testing Alternate-day oral Iron (III)-hydroxide polymaltose complex and Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing in people with Iron Deficiency Anemia, run by University of Medicine, Mandalay at 2 sites in Burma.
Trial summary
The goal of this clinical trial is to find out whether Iron (III)-hydroxide polymaltose complex (IPC) given on an alternate-day schedule works as well as daily dosing in treating iron deficiency anaemia in children. The study will also look at the safety and tolerability of IPC. Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Alternate-day oral Iron (III)-hydroxide polymaltose complex and Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBurma
- Study dates
- 1 Feb 2026to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 6 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Critically ill child
- Children with documented chronic illnesses (e.g., known renal failure, known liver disease)
- Children with known cases of thalassemia
- Children with severe anaemia requiring transfusion
- Children who received blood transfusion within the preceding 3 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Burma2 sites
Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay
Mandalay, Mandalay Region
Kyaw Myo, Professor of Paediatrics, +959798599253, kyawmyo@ummedu.com
Zayar Kyaw Win, MBBS, MMedSc (Paediatrics)
Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay
Mandalay, Mandalay Region
Kyaw Myo, Professor of Paediatrics, +959798599253, kyawmyo@ummedu.com
About this study
The goal of this clinical trial is to find out whether Iron (III)-hydroxide polymaltose complex (IPC) given on an alternate-day schedule works as well as daily dosing in treating iron deficiency anaemia in children. The study will also look at the safety and tolerability of IPC.
The main questions this study aims to answer are:
Read more
Does alternate-day oral IPC improve haemoglobin levels and serum ferritin level as effectively as daily oral IPC?
Does alternate-day dosing reduce gastrointestinal side effects compared to daily dosing?
Does alternate-day dosing improve treatment adherence in children?
Researchers will compare alternate-day IPC with daily IPC to determine the most effective and well-tolerated dosing schedule for children with iron deficiency anaemia.
Participants will:
Receive oral Iron (III)-hydroxide polymaltose complex either daily or on alternate days for 12 weeks treatment period
Attend regular clinic visits for clinical assessment and blood investigations
Be monitored for adverse effects, adherence to treatment, and improvement in haemoglobin and serum ferritin levels
- Conditions
- Iron Deficiency Anemia
- Being tested
- Alternate-day oral Iron (III)-hydroxide polymaltose complex, Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing
- 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.
Alternate-day oral Iron (III)-hydroxide polymaltose complexDrug
The intervention uses the same oral Iron (III)-hydroxide polymaltose complex in both study arms, differing only in dosing frequency (alternate-day versus daily administration)
Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosingDrug
This intervention uses oral Iron (III)-hydroxide polymaltose complex, a non-ionic ferric iron preparation, administered as a liquid formulation with dosing based on body weight. This study evaluates the same iron preparation in both study arms, with the dosing frequency (daily versus alternate-day administration) as the only variable. This approach allows assessment of the impact of dosing schedule on haemoglobin response, gastrointestinal tolerability, and treatment adherence in children with iron deficiency anaemia, while minimizing confounding from formulation-related differences.
| Study group | Role | What they receive |
|---|---|---|
| Alternate-day group | Experimental | Alternate-day group receiving oral iron III polymaltose complex 3mg/kg/day Receives: Drug: Alternate-day oral Iron (III)-hydroxide polymaltose complex; Drug: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing |
| Daily group | Experimental | Daily group receiving oral iron III polymaltose complex 3mg/kg/day Receives: Drug: Alternate-day oral Iron (III)-hydroxide polymaltose complex; Drug: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia
To compare the difference in mean haemoglobin concentration, mean serum ferritin level after 12 weeks of oral iron therapy between alternate-day and daily oral iron therapy in children with iron deficiency anaemia
Measured: 1 year duration
Secondary outcomes (1)
To compare the difference in mean haemoglobin concentration, mean serum ferritin level after 12 weeks of oral iron therapy between alternate-day and daily oral iron therapy in children with iron deficiency anaemia
Measured: one year duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as an interventional, randomized, parallel-group clinical trial. Eligible children ( total 60) with iron deficiency anaemia will be randomly assigned in a 1:1 ratio to one of two intervention groups. One group will receive oral Iron (III)-hydroxide polymaltose complex administered daily, while the other group will receive the same preparation on an alternate-day schedule. Each participant will remain in their allocated group throughout the study period, with no crossover between interventions. The parallel assignment model is chosen to allow direct comparison of the efficacy, safety, and adherence between the two dosing regimens while avoiding carryover effects, which are particularly relevant in treatments affecting serum ferritin and haemoglobin levels. The primary purpose of the study is treatment, and outcomes will be assessed through clinical evaluation and laboratory measurements over the 12 weeks follow-up period.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine, Mandalay
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zayar Kyaw Win, University of Medicine, Mandalay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391371
- Sponsor's protocol ID
- UMM-13(1/2025)
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternate-day Versus Daily Oral Iron Therapy in Children With Iron Deficiency Anaemia
- ClinicalTrials.gov ID
- NCT07391371
- Acronym / sponsor ID
- UMM-13(1/2025)
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Medicine, MandalayUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Feb 2026 (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.
The goal of this clinical trial is to find out whether Iron (III)-hydroxide polymaltose complex (IPC) given on an alternate-day schedule works as well as daily dosing in treating iron deficiency anaemia in children. The study will also look at the safety and tolerability of IPC.
The main questions this study aims to answer are:
Does alternate-day oral IPC improve haemoglobin levels and serum ferritin level as effectively as daily oral IPC?
Does alternate-day dosing reduce gastrointestinal side effects compared to daily dosing?
Does alternate-day dosing improve treatment adherence in children?
Researchers will compare alternate-day IPC with daily IPC to determine the most effective and well-tolerated dosing schedule for children with iron deficiency anaemia.
Participants will:
Receive oral Iron (III)-hydroxide polymaltose complex either daily or on alternate days for 12 weeks treatment period
Attend regular clinic visits for clinical assessment and blood investigations
Be monitored for adverse effects, adherence to treatment, and improvement in haemoglobin and serum ferritin levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is designed as an interventional, randomized, parallel-group clinical trial. Eligible children ( total 60) with iron deficiency anaemia will be randomly assigned in a 1:1 ratio to one of two intervention groups. One group will receive oral Iron (III)-hydroxide polymaltose complex administered daily, while the other group will receive the same preparation on an alternate-day schedule. Each participant will remain in their allocated group throughout the study period, with no crossover between interventions. The parallel assignment model is chosen to allow direct comparison of the efficacy, safety, and adherence between the two dosing regimens while avoiding carryover effects, which are particularly relevant in treatments affecting serum ferritin and haemoglobin levels. The primary purpose of the study is treatment, and outcomes will be assessed through clinical evaluation and laboratory measurements over the 12 weeks follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Alternate-day group | Experimental | Drug: Alternate-day oral Iron (III)-hydroxide polymaltose complex, Drug: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosingAlternate-day group receiving oral iron III polymaltose complex 3mg/kg/day |
| Daily group | Experimental | Drug: Alternate-day oral Iron (III)-hydroxide polymaltose complex, Drug: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosingDaily group receiving oral iron III polymaltose complex 3mg/kg/day |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Critically ill child
- Children with documented chronic illnesses (e.g., known renal failure, known liver disease)
- Children with known cases of thalassemia
- Children with severe anaemia requiring transfusion
- Children who received blood transfusion within the preceding 3 months
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 |
|---|---|---|
| Alternate-day oral Iron (III)-hydroxide polymaltose complexThe intervention uses the same oral Iron (III)-hydroxide polymaltose complex in both study arms, differing only in dosing frequency (alternate-day versus daily administration) | Drug | Alternate-day group, Daily group |
| Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosingThis intervention uses oral Iron (III)-hydroxide polymaltose complex, a non-ionic ferric iron preparation, administered as a liquid formulation with dosing based on body weight. This study evaluates the same iron preparation in both study arms, with the dosing frequency (daily versus alternate-day administration) as the only variable. This approach allows assessment of the impact of dosing schedule on haemoglobin response, gastrointestinal tolerability, and treatment adherence in children with iron deficiency anaemia, while minimizing confounding from formulation-related differences. | Drug | Alternate-day group, Daily group |
Primary outcome
To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia
Time frame: 1 year duration
To compare the difference in mean haemoglobin concentration, mean serum ferritin level after 12 weeks of oral iron therapy between alternate-day and daily oral iron therapy in children with iron deficiency anaemia
1 secondary outcome
To compare the difference in mean haemoglobin concentration, mean serum ferritin level after 12 weeks of oral iron therapy between alternate-day and daily oral iron therapy in children with iron deficiency anaemia
Time frame: one year duration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alternate-day oral Iron (III)-hydroxide polymaltose complex and Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing in people with Iron Deficiency Anemia, run by University of Medicine, Mandalay at 2 sites in Burma.
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 0 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Feb 2026. 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 Burma. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zayar Kyaw Win, MBBS, MMed Sc (Paediatrics) (+9595123141, dr.zayar.k.w@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia (time frame: 1 year duration). 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 5 Feb 2026.