| CTRI Number |
CTRI/2024/11/077412 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of an oral drug, N-Acetylcysteine on reducing the quantity of blood transfusion requirement in children with Beta thalassemia who are alreaady receiving regular blood transfusion |
|
Scientific Title of Study
|
The effect of N-Acetylcysteine on red blood cell transfusion burden in transfusion dependent Beta thalassemia children A open labelled experimental study |
| 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 Shajathi Begum N |
| Designation |
Assistant professor |
| Affiliation |
Institute of child health,Egmore,Chennai |
| Address |
C-block, Floor 7, Department of Pediatric hemato-oncology, ICH and HC, Egmore, Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9524543046 |
| Fax |
|
| Email |
shaju9875@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shajathi Begum N |
| Designation |
Assistant professor |
| Affiliation |
Institute of child health,Egmore,Chennai |
| Address |
C-block, Floor 7, Department of Pediatric hemato-oncology, ICH and HC, Egmore, Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9524543046 |
| Fax |
|
| Email |
shaju9875@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shajathi Begum N |
| Designation |
Assistant professor |
| Affiliation |
Institute of child health,Egmore,Chennai |
| Address |
C-block, Floor 7, Department of Pediatric hemato-oncology, ICH and HC, Egmore, Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
9524543046 |
| Fax |
|
| Email |
shaju9875@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multidisciplinary Research Unit
Health and research
Department of Health and Family Welfare
New Delhi |
|
|
Primary Sponsor
|
| Name |
Multidisciplinary Research Unit |
| Address |
Multidisciplinary Research Unit
Health and research
Department of Health and Family Welfare
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 Shajathi Begum N |
Institute of Child Health |
C-block, Floor 7, Department of Pediatric hemato-oncology, Institute of Child Health, Egmore, Chennai - 600008
Chennai
TAMIL NADU |
9524543046
shaju9875@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Madras Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D561||Beta thalassemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Use of N-Acetylcysteine |
Use of N-Acetylcysteine - 10 mg/kg/day administered orally for a period of 3 months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All transfusion dependent Beta thalassemia children on regular blood transfusion and iron chelation therapy
Serum ferritin 2500-3000ng/ml |
|
| ExclusionCriteria |
| Details |
Renal/hepatic impairment
Change in dose of iron chelater within three months before enrolment
Alloimmunisation |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in burden of RBC transfusion
Increase in hemoglobin levels |
1. Total volume of blood transfused over the last three months will be assessed at baseline prior to starting N-Acetylcisteine. At the end of study period, the volume of blood transfused over the last 3 months will be assessed
2. Pre-transfusion Hb will be checked at baseline, every 3 weeks and at the end of study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Serum ferritin |
Serum ferritin will be checked at baseline, at the end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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 4 |
|
Date of First Enrollment (India)
|
08/12/2024 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shaju9875@gmail.com].
- For how long will this data be available start date provided 01-02-2026 and end date provided 31-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Two to twelve years old Beta thalassemia children on regular blood transfusion and iron chelation will be considered for the study.After applying the inclusion and exclusion criteria and obtaining informed written consent from the parents,children will be enrolled as study group.Baseline characteristics,mean pretransfusion Hb,LFT,Serum ferritin,transfusion volume over the last three months will be recorded.NAC will be administered at a dose of 10mg/kg/day.At their regular follow up(3 to 4weeks interval),per transfusion Hb and volume of transfusion will be noted.At the end of three months,mean per transfusion Hb,volume of transfusion over last three months and Serum ferritin will be noted.Statistical association will be analysed using paired t test.p value less than 0.05 will be considered significant . Durin the study period,patients will be called over telephone everyday for the initial two weeks and weekly once thereafter to ensure compliance and also address their concerns if any.Empty tablet blisters will be checked at regular follow up. |