Iron Deficiency Anemia
Conditions
Brief 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. 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
Interventions
DRUGAlternate-day oral Iron (III)-hydroxide polymaltose complex
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)
DRUGIron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing
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.
Sponsors
University of Medicine, Mandalay
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
Yes
Inclusion criteria
Six months to 12 years old children with iron deficiency anaemia
Exclusion criteria
1. Critically ill child 2. Children with documented chronic illnesses (e.g., known renal failure, known liver disease) 3. Children with known cases of thalassemia 4. Children with severe anaemia requiring transfusion 5. Children who received blood transfusion within the preceding 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia | 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 |
Secondary
| Measure | 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 |
Countries
Burma
Contacts
CONTACTZayar Kyaw Win, MBBS, MMed Sc (Paediatrics)
Outcome results
None listed