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CTRI Number  CTRI/2024/06/068424 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Microencapsulated ferrous saccharate as a newer formulation has better efficacy than colloidal elemental iron in treatment of iron deficiency anemia in 5-15years age group 
Scientific Title of Study   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 Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kag Rakesh Choudhary 
Designation  Paediatric Resident  
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of paediatrics, Jawaharlal Nehru Medical College, Nehru nagar, KLE hospital Road Belagaum KARNATAKA 590010 INDIA
Nehru nagar, KLE Hospital road, Belagaum KARNATAKA
Belgaum
KARNATAKA
590010
India 
Phone  9177876965  
Fax    
Email  kagrakesh2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tanmaya Metgud 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of paediatrics, Jawaharlal Nehru Medical College, Nehru nagar, KLE hospital Road Belagaum KARNATAKA 590010 INDIA
Nehru nagar, KLE Hospital road, Belagaum KARNATAKA
Belgaum
KARNATAKA
590010
India 
Phone  9845395294  
Fax    
Email  tanmayametgud@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kag Rakesh Choudhary 
Designation  Paediatric Resident  
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of paediatrics, Jawaharlal Nehru Medical College, Nehru nagar, KLE hospital Road Belagaum KARNATAKA 590010 INDIA
Nehru nagar, KLE Hospital road, Belagaum KARNATAKA

KARNATAKA
590010
India 
Phone  9177876965  
Fax    
Email  kagrakesh2@gmail.com  
 
Source of Monetary or Material Support  
Dr KLE Prabhakar kore hospital JNMC medical college nehru nagar Belgaum Karnataka India 590010 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College KLE university Belagavi 
Address  Department of paediatrics Jawaharlal nehru medical college Nehru nagar, belagavi Karnataka, 590010 590010  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Choudhary   KLEs Dr Prabhakar Kore hospital Belagavi  Department of Paediatrics, Jawaharlal Nehru Medical College Nehru Nagar KLE Hospital Road Belgaum Belgaum KARNATAKA
Belgaum
KARNATAKA 		 9177876965

kagrakesh2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R718||Other abnormality of red blood cells,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Microencapsulated ferrous saccharate used in iron deficiency anemia patients to intervene iron profile and anemia profile  Hemoglobin levels improvement after 3months of follow ups children 5–12 years: 11.5 g/dl children 12-18 years:12 g/dl 
Comparator Agent  Microencapsulated ferrous saccharate versus colloidal elemental iron  1. Dose-(3-4mg/kg/day) 2.Frequency- 1or2 strips per day 3.Oral route of administration 4. Total three months of duration 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  1.Children aged less than 5 years because of increased chances of choking risk
2. Subjects Who are already on iron supplementation
3. Subjects with hypersensitivity to any of the ingredients of the product (such as lactose)
4. Children with severe anemia who are in need of parenteral supplementation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of microencapsulated ferrous saccharate vs colloidal elemental iron for treatment of iron deficiency anemia  Hemoglobin, MCV, MCH, MCHC, Iron profile is assessed at the time of diagnosis and at 3months after treatment  
 
Secondary Outcome  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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