| CTRI Number |
CTRI/2025/09/095049 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Heme Iron polypeptide versus Ferrous sulphate in children with Iron Deficiency Anemia- Randomised Control Trial |
|
Scientific Title of Study
|
Evaluation of efficacy of Heme Iron Polypeptide in comparison to Ferrous sulphate in children with Iron Deficiency Anemia- Randomised 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 Arshiya Shaikh |
| Designation |
1st year Paediatrics PG student |
| Affiliation |
KAHER Jawaharlal Nehru Medical College Belgaum |
| Address |
1st year PG student
DEPT OF PAEDIATRICS
KAHER
Jawaharlal Nehru Medical College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9449536551 |
| Fax |
|
| Email |
saleemshaikh1964@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhilasha Sampagar |
| Designation |
Professor |
| Affiliation |
KAHER Jawaharlal Nehru Medical College Belgaum |
| Address |
Professor
Paediatric Hematologist Oncologist
DEPT OF PAEDIATRIC Hematology oncology
KAHER
Jawaharlal Nehru Medical College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9686187023 |
| Fax |
|
| Email |
abhilasha.pedia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilasha Sampagar |
| Designation |
Professor |
| Affiliation |
KAHER Jawaharlal Nehru Medical College Belgaum |
| Address |
Professor
Paediatric Hematologist Oncologist
DEPT OF PAEDIATRICS Hematology Oncology
KAHER
Jawaharlal Nehru Medical College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9686187023 |
| Fax |
|
| Email |
abhilasha.pedia@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER
Jawaharlal Nehru Medical College, Belgaum |
|
|
Primary Sponsor
|
| Name |
Dr Arshiya Shaikh |
| Address |
1st year PG student
Dept of Paediatrics
KAHER
Jawaharlal Nehru Medical College
Belgaum, Karnataka 590010 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arshiya Shaikh |
Jawaharlal Nehru Medical College |
Dept of Paediatrics
Paediatric ward
Belgaum
KARNATAKA |
9449536551
saleemshaikh1964@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ferrous sulphate oral |
Oral Ferrous sulphate will be given in two divided doses at four MG per kg daily. We are comparing the rise in hemoglobin and side effects with ferrous sulphate. Ferrous sulphate will be given for 84 days after which CBC will be repeated. |
| Intervention |
Heme Iron
Polypeptide tablet |
Oral 12 MG heme iron polypeptide tablet is a new type of iron preparation which is derived directly from hemoglobin hence is metabolised faster with lesser side effects,to be given once daily in children less than 20 kg AND twice daily for children more than 20 kg. The tablets will be given for 84 days, after which CBC will be repeated. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All children between 1 year to 18 years with Iron Deficiency Anemia |
|
| ExclusionCriteria |
| Details |
1. Patients who have received blood transfusion in the last three months
2. Patients who received iv Iron in the last one month
3. Patients who have malabsorption syndrome and inflammatory bowel disease
4. Patients who suffer from chronic blood loss like portal hypertension, anastomosis leak from surgical site, hemorrhoids, polyp, etc
5. Patients not consenting for study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in hemoglobin with heme Iron polypeptide in comparison to Ferrous sulphate in children in Iron Deficiency Anemia |
After 84 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation between heme Iron polypeptide & Ferrous sulphate on hepcidin levels |
After 24 hours of initiating intervention |
| Gastro intestinal side effects in both groups of heme Iron polypeptide & Ferrous sulphate |
Every week after starting intervention till 84 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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 Applicable |
| 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 affects around 67 percent of Indian children, making it a major public health problem. Oral iron supplementation is the mainstay of treatment, but ferrous salts often cause gastrointestinal side effects. Heme Iron Polypeptide- HIP shows superior bioavailability and better tolerance compared to ferrous sulphate. Evidence suggests HIP may improve hemoglobin more effectively, but comparative studies in children are limited. This study is an open-labeled randomized controlled trial conducted at KAHER JNMC, Belagavi, comparing efficacy of heme Iron polypeptide versus Ferrous sulphate in children with Iron Deficiency Anemia. A total of 84 children aged 1 to 18 years with IDA will be randomized into two groups. Group 1 will receive HIP, while Group 2 will receive ferrous sulphate, both as daily oral therapy. Blood investigations and detailed physical examination will be done, and the children will be followed up telephonically.
Primary outcome is hemoglobin rise after 84 days of treatment Secondary outcomes are hepcidin levels association and GI side effects. Data will be analyzed using appropriate statistical methods, with significance at p less than 0.05. The study aims to determine whether HIP is a more effective and safer alternative to ferrous sulphate in treating pediatric IDA. |