| CTRI Number |
CTRI/2024/10/075756 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Hospital based |
| Study Design |
Other |
|
Public Title of Study
|
A study to know about how the screening tools are used for iron deficiency anemia are helpful by easily calculating and to provide treatment with simple methods of calculations |
|
Scientific Title of Study
|
Evaluation of Mentzer index and red cell distribution width index as screening tools for iron deficiency anemia in children 6 months to 15 years of age in a tertiary care hospital |
| 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 Sirishree |
| Designation |
Post graduate |
| Affiliation |
BGS Global Institute of medical science |
| Address |
Department of Paediatrics
BGS Global Institute of Medical Science Kengeri Bangalore
Deparment of Pediatrics
BGS Global Institute of Medical Science Kengeri Bangalore
Mysore
KARNATAKA
560060
India |
| Phone |
7598230776 |
| Fax |
|
| Email |
sirishreebadrinath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purnima Samayam |
| Designation |
Professor |
| Affiliation |
BGS Global Institute of medical science |
| Address |
Department of Paediatrics
BGS Global Institute of Medical Science Kengeri Bangalore
BGS Global Institute of Medical Science Kengeri Bangalore
Bangalore
KARNATAKA
560060
India |
| Phone |
9902574134 |
| Fax |
|
| Email |
purnimasamayam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sirishree |
| Designation |
Post graduate |
| Affiliation |
BGS Global Institute of medical science |
| Address |
Department of Pediatrics
BGS Global Institute of Medical Science Kengeri Bangalore
Department of Pediatrics
BGS Global Institute of Medical Science Kengeri Bangalore
Mysore
KARNATAKA
560060
India |
| Phone |
7598230776 |
| Fax |
|
| Email |
sirishreebadrinath@gmail.com |
|
|
Source of Monetary or Material Support
|
| BGS Global Institue of Medical Science,Kengeri,Bangalore,India,560060 |
|
|
Primary Sponsor
|
| Name |
Sirishree |
| Address |
BGS Global Institute Of Medical Science,Kengeri,Bangalore,India
560060 |
| 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 Sirishree |
BGS Global Institute of Medical Science |
Department of Pediatrics/Room No:4
Bangalore
KARNATAKA |
7598230776
sirishreebadrinath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES INSTITUTE ETHICS COMITTEE |
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 |
children |
3-4 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6 months to 15 years
2. Pallor on clinical examination with haemoglobin below WHO cutoff for age
3. Children with microcytic hypochromic anemia
|
|
| ExclusionCriteria |
| Details |
1. Acutely sick children
2. Intercurrent IIlness
3. Diagnosed cases of hemolytic anemias, megaloblastic anemia, anemia of chronic disease
4. Children on treatment with iron
5. Children who have received blood transfusion in last 3 months
6. Children for whom consent is not obtained
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate validity of Mentzer index and Red cell Distribution Width Index as screening tools for iron deficiency anemia |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To analyse Red Blood Cell count in various age groups and grades of severity of iron deficiency anemia |
1 year |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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
|
Anemia is
defined as reduction in hemoglobin concentration. Almost 30% of world’s population is affected by anemia due to various
causes of which iron deficiency anemia is a main contributor. Anemia poses
public health challenge and is especially important in paediatric age group
since nearly 6-7 out of 10 children under 5 years of age are anemic .Iron
deficiency adversely affects physical growth, behavior and cognitive
performance of the young and school age children. It also adversely affects the
immune status and predisposes to morbidity and mortality from infections in all
age groups. Hence there is need for early detection and intervention to reduce
these adverse outcomes associated with iron deficiency anemia. Anemia is
diagnosed using clinical symptoms and signs along with hemoglobin percentage,
serum iron, total iron binding capacity and serum ferritin levels. In limited
source settings, iron deficiency anemia is also diagnosed using hemoglobin
percentage, peripheral smear showing microcytic hypochromic red blood cells and
clinical response to iron therapy. In a resource poor country like India, iron
studies especially serum ferritin which is currently the gold standard test for
iron deficiency anemia is expensive and time consuming and may not be available
in many peripheral laboratories. In such settings, economical yet effective
screening modalities are required that would aid in diagnosis. Red blood cell
parameters like Red Blood Cell Count(RBC) , Mean Corpuscular Volume(MCV), Mean
Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration(MCHC),
Red cell Distribution Width(RDW), Peripheral Smear (PS) and some calculated
indices like Mentzer index, Red cell Distribution Width index can be used as
screening tools for iron deficiency anemia in children. |