| CTRI Number |
CTRI/2010/091/002994 [Registered on: 14/12/2010] |
| Last Modified On: |
27/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Ferrous Ascorbate in the treatment of IDA |
Scientific Title of Study
Modification(s)
|
Efficacy and safety of Ferrous Ascorbate and Colloidal Iron in pediatric patients with iron deficiency anemia: An open, randomized, comparative trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Zuv/Fern/Susp/1/2008 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sutapa Ganguly |
| Designation |
Principal Investigator |
| Affiliation |
NRS Medical College and Hospital |
| Address |
138-Acharya Jagadish Chandra Bose Road
Kolkata
WEST BENGAL
700 014
India |
| Phone |
09831369441 |
| Fax |
|
| Email |
sutapaganguly@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd. |
| Address |
5119-D Wing, Oberoi Garden Estate
Chandivilli,
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
02230610000 |
| Fax |
|
| Email |
Bhupesh.Dewan@zuventus.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
5119-D Wing, Oberoi Garden Estate Chandivali, Andheri (E)
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
02230610000 |
| Fax |
|
| Email |
Bhupesh.Dewan@zuventus.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Zuventus Healthcare Ltd.
5119-D Wing, Oberoi Garden Estate, Chandivali, Mumbai 400 072 |
|
Primary Sponsor
Modification(s)
|
| Name |
Zuventus Healthcare Ltd |
| Address |
Office no 5119, D wing 5th floor Oberoi Garden Estates Chandivali Andheri (E) Mumbai- 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sutapa Ganguly |
NRS Medical College and Hospital. |
138-Acharya Jagadish Chandra Bose Road, ,-700 014
Kolkata
WEST BENGAL |
9831369441
sutapaganguly@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nilratan Sircar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E611||Iron deficiency, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
FERONIA-XT Suspension |
Elemental Iron 3 mg/kg body weight |
| Comparator Agent |
Tonoferon Syrup |
Elemental Iron 3 mg/kg body weight |
|
Inclusion Criteria
Modification(s)
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
?Children between the age group of 6 months to 12 years.
?Children having iron deficiency anemia with hemoglobin less than 10 gm%.
?Patients who would be coming for follow up after every 4 weeks for the complete study period of 12 weeks.
?Informed written consent given by parents/guardians of the patients.
|
|
| ExclusionCriteria |
| Details |
?Anemia due to other causes than iron deficiency anemia
?Severe concurrent illness (cardiovascular, renal, hepatic).
?Known hypersensitivity to Ferrous ascorbate or any other iron preparations
?Malignancy of any type.
?Children with thalassemia major / aplastic or hypoplastic anaemia, sickle cell anaemia, any other abnormal haemoglobinopathy or any other haemolytic anaemia.
?Any other condition that in the opinion of the investigator does not justify the patient?s inclusion.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Increase in hemoglobin level |
End of week 4, Week 8, week 12 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Change in hemoglobin levels based on the severity of anemia at baseline (moderate anemia corresponds to a level of 7.0-9.9 gm%
while severe anemia corresponds to a level less than 7.0 gm%),
2. changes in other iron
indices, responder rate defined as the proportion of children becoming non-anemic [Hb more than or equal to
11 gm %] and
3. Incidence of any adverse events. |
1. Week 12
2. Week 12
3. Throughout study duration. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
01/01/2009 |
| Date of Study Completion (India) |
30/11/2009 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Ganguly S, Dewan B, Philipose N, Samanta T, Paul DK, Purkait R. Comparison between Ferrous Ascorbate and Colloidal Iron in the Treatment of Iron Deficiency Anemia in Children from Kolkata, India. British Journal of Medicine and Medical Research. 2012 Apr 1;2(2):195. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
the present study compares the efficacy of ferrous ascorbate and colloidal iron in the treatment of Iron deficiency anemia in children. Children eligible for inclusion will be randomized to receive either Feronia-XT or Tonoferon for a period of 3 months. the dosage of the iron supplementation will be calculated such that each child receives 3 mg/kg elemental iron for 12 weeks. Assessment for the change in iron indices will be performed at the baseline (Day 0), Week 4, Week 8 and Week 12. |