| CTRI Number |
CTRI/2024/05/067099 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the efficacy of different oral iron preparations for Iron Deficiency anemia in Children |
|
Scientific Title of Study
|
To compare the efficacy of supplementation with different oral iron formulations in children with Iron Deficiency Anemia |
| 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 Nikhil Mishra |
| Designation |
Junior Resident |
| Affiliation |
Dr SN Medical College ,Jodhpur |
| Address |
MDM Hospital ,Department of Pediatrics ,
Shastri Nagar, Jodhpur ,342003
Jodhpur
RAJASTHAN
343003
India |
| Phone |
8982131117 |
| Fax |
|
| Email |
nikhil95mishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Sharma |
| Designation |
Senior Professor |
| Affiliation |
Department Of Pediatrics , Dr SNMC ,Jodhpur |
| Address |
Ground Floor Room 2
Department of pediatrics
Ankur Hospital, Paota C Road ,Jodhpur
Jodhpur
RAJASTHAN
342006
India |
| Phone |
9929744666 |
| Fax |
|
| Email |
drpramodsha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Sharma |
| Designation |
Senior Professor |
| Affiliation |
Department Of Pediatrics , Dr SNMC ,Jodhpur |
| Address |
Ground Floor Room 2
Department of pediatrics
Ankur Hospital, Paota C Road ,Jodhpur
Jodhpur
RAJASTHAN
342006
India |
| Phone |
9929744666 |
| Fax |
|
| Email |
drpramodsha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN Medical College , Jodhpur (GOvt Medical College) |
|
|
Primary Sponsor
|
| Name |
Dr SN Medical College |
| Address |
Dr SN Medical College
Jodhpur , 342003
Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Nikhil Mishra |
Dr SN Medical College ,Jodhpur |
Department of Pediatrics Umaid Hospital /Emergency building / Room 18
Jodhpur
RAJASTHAN |
8982131117
nikhil95mishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , DR SAMPURNANAND MEDICAL COLEGE,JODHPUR |
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 |
| Intervention |
SYP FERROUS ASCORBATE |
To be given oral ,once daily with dose of 5mg/kg/day To be given for 3 month
|
| Comparator Agent |
SYRUP CARBONYL IRON |
To be given orally, once daily at a dose of 5mg/kg/day to be given for 3 months. |
| Comparator Agent |
SYRUP FERROUS AMMONIUM CITRATE |
To be given orally, once daily at a dose of 5mg/kg/day to be given for 3 months |
| Comparator Agent |
SYRUP LIPOSOMAL IRON |
To be given orally ,once daily at a dose of 5mg/kg/day to be given for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
All children of this age group attending OPD of Umaid Hospital ,those who fulfill the chinese medical criteria of iron deficiency anemia shall be recruited for study. |
|
| ExclusionCriteria |
| Details |
1. All known cases of conditions that cause disruption in iron metabolism like celiac disease , thalassemia ,chronic malabsorption syndrome will not be included.
2. all cases on any kind of iron therapy or given any blood transfusion in past 1 month |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in hemoglobin |
1 month 2 month 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in RDW , MCV and ferritin level |
1 month 2 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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
|
To determine the efficacy of supplementation of different oral iron formulations to children of iron deficiency anemia in raising their hemoglobin levels |