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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternate-day group | Experimental | Alternate-day group receiving oral iron III polymaltose complex 3mg/kg/day |
|
| Daily group | Experimental | Daily group receiving oral iron III polymaltose complex 3mg/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternate-day oral Iron (III)-hydroxide polymaltose complex | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year duration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year duration |
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Inclusion criteria Six months to 12 years old children with iron deficiency anaemia
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zayar Kyaw Win, MBBS, MMed Sc (Paediatrics) | Contact | +9595123141 | dr.zayar.k.w@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay | Mandalay | Mandalay Region | Burma |
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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.
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| Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing | Drug | 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. |
|
| Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay | Mandalay | Mandalay Region | Burma |
|
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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