| CTRI Number |
CTRI/2024/06/068445 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the effectiveness between liposomal iron and conventional iron in the treatment of iron deficiency anaemia in children aged 6months-5years. |
|
Scientific Title of Study
|
Comparison of the Effectiveness between Liposomal Iron and Conventional Iron in the Treatment of Iron Deficiency Anaemia - A 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 Suresh R |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of paediatrics
SRM Medical College Hospital and Research Centre
Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9940403011 |
| Fax |
|
| Email |
surmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh R |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of paediatrics
SRM Medical College Hospital and Research Centre
Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9940403011 |
| Fax |
|
| Email |
surmbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh R |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of paediatrics
SRM Medical College Hospital and Research Centre
Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9940403011 |
| Fax |
|
| Email |
surmbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital & Research Centre, S.R.M Nagar, Potheri,
Kattankulathur, Chengalpattu - 603203, Tamilnadu, India. |
|
|
Primary Sponsor
|
| Name |
Dr Suresh R |
| Address |
Associate Professor,
Department of Paediatrics,
SRM Medical College Hospital & Research Centre, S.R.M Nagar, Potheri, Kattankulathur, Chengalpattu - 603203, Tamilnadu, India. |
| 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 R Suresh |
SRM Medical College Hospital and Research Centre |
Room No : 14, C Block, Department of Paediatrics, S.R.M Nagar, Potheri,
Kattankulathur, Chengalpattu-603203, Tamilnadu, India.
Chennai
TAMIL NADU |
9940403011
surmbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRM Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ferrous Ascorbate suspension |
Ferrous Ascorbate at a dose of 3mg/kg/day of Elemental Iron for 1month. |
| Intervention |
Liposomal Iron syrup, Iron Polymaltose syrup. |
Liposomal Iron at a dose of 1mg/kg/day for 1month, Iron Polymaltose at a dose of 3mg/kg/day of Elemental Iron for 1month. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children with Mild to Moderate Iron Deficiency Anaemia
Children with no other haematological disorders
Children not started on any iron supplements in last 3 months
children without any active infections |
|
| ExclusionCriteria |
| Details |
Children who are already on treatment
Children with other medical condition. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the effectiveness between Liposomal Iron, Iron Polymaltose complex and Ferrous Ascorbate. |
At the time of diagnosis and one month after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare the oral tolerability and side effect profile between liposomal Iron, Iron polymaltose complex and Ferrous Ascorbate |
At one month after treatment |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "98"
Final Enrollment numbers achieved (India)="98" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2024 |
| Date of Study Completion (India) |
23/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Study Hypothesis : Can the Liposomal Iron cause a quicker response and better tolerance as compared to conventional Iron? Study Justification : Iron deficiency Anaemia is more prevalent among growing children and the Iron formulations usually has adverse effects such as constipation, diarrhoea and unpleasant taste and it leads to poor compliance and hence the study aims to compare the effectiveness between conventional Iron and Liposomal Iron with regards to clinical response , oral tolerability and side effect profile. |