To assess the Efficacy of Microencapsulated Ferric Saccharate as a Novel Oral Iron Strip vs Colloidal Elemental Iron for treatment of Iron Deficiency Anemia in children- Randomized control trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of microencapsulated ferrous saccharate vs colloidal elemental iron for treatment of iron deficiency anemia
Study Overview
Brief Summary
Iron deficiency anemia (IDA) is a prevalent global health issue characterized by a deficiency of iron, a crucial micronutrient for erythropoiesis. This condition significantly impacts individuals of all ages, leading to fatigue, weakness, and impaired cognitive function. This study aims to explore the newer formulations in the treatment of iron deficiency anemia. Limitations of conventional iron salts have resulted in emergence of newer oral iron preparations like microencapsulated ferric saccharate, carbonyl iron, iron polymaltose complex, ferrous ascorbate, sodium feredetate and ferrous bisglycinate. The objective of oral iron strips used in iron deficiency anemia treatment is to provide a convenient and effective way to supplement iron. The micro-encapsulated iron AB-Fortis® presents a solution. In this unique technology, the iron is protected and kept stable by a natural, organic layer which avoids the release of free iron. As a result, there is no metallic taste, oxidation or negative gastrointestinal side effects. The oral strips offer an alternative to traditional iron supplements, such as tablets or capsules, and can be particularly beneficial for those who may have difficulty swallowing pills. The benefits of AB-Fortis iron is its uniform and defined dose, which is kept constant among batches, always around 40% of iron by weight and another crucial advantage of AB-Fortis is the minimal release of iron from the microcapsules during its storage, which prevents the classical side effects of the administration of free iron: metallic taste, dental darkening, abdominal pain, black feces and avoiding the oxidation of folic acid and omega-3 fatty acids.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •children aged between 5-18 years of age diagnosed as iron deficiency anemia attending Inpatient & outpatient department in KLE’S Dr.Prabhakar Kore Hospital and Medical Research Centre, Belagavi.
Exclusion Criteria
- •1.Children aged less than 5 years because of increased chances of choking risk
- •Subjects Who are already on iron supplementation
- •Subjects with hypersensitivity to any of the ingredients of the product (such as lactose)
- •Children with severe anemia who are in need of parenteral supplementation.
Outcomes
Primary Outcomes
To assess the efficacy of microencapsulated ferrous saccharate vs colloidal elemental iron for treatment of iron deficiency anemia
Time Frame: Hemoglobin, MCV, MCH, MCHC, Iron profile is assessed at the time of diagnosis and at 3months after treatment
Secondary Outcomes
- To study the side effects & compliance of oral preparations(Side effects & compliance assessed at 1 month & at 3 months of follow up by asking questionnaire)
Investigators
Dr Kag Rakesh Choudhary
Jawaharlal Nehru Medical College
