| CTRI Number |
CTRI/2015/05/005776 [Registered on: 14/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
16/05/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study of mature and immature red blood cell indices in iron deficiency status |
|
Scientific Title of Study
|
Study of erythrocytes and reticulocyte indices in iron deficiency status. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Salman Akther |
| Designation |
Post graduate Resident |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Pathology,Central Laboratory,Father Muller Medical College,Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8152840903 |
| Fax |
|
| Email |
dr.salmanakhter25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayaprakash CS |
| Designation |
Professor |
| Affiliation |
Father muller medical college |
| Address |
Department of Pathology,
Father muller medical college
Kankanady
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9448254675 |
| Fax |
|
| Email |
csjayaprakash@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Salman Akther |
| Designation |
Post graduate Resident |
| Affiliation |
Father Muller Medical College |
| Address |
Department of pathology,
Father muller medical college
kankanady
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8152840903 |
| Fax |
|
| Email |
dr.salmanakhter25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Salman Akther |
| Address |
Department of Pathology |
| Type of Sponsor |
Other [] |
|
|
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 Salman Akther |
Hematology division, Central lab , Father muller medical college |
Father muller medical college,
Kankanady, Mangalore 575002
Dakshina Kannada
KARNATAKA |
8152840903
dr.salmanakhter25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| father muller institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
anemic patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
hemoglobin,MCV,MRV,MCHC,MCH,Rsf,LDH% |
|
| ExclusionCriteria |
| Details |
pediatric age group,normocytic normochromic anemia, macrocytic anemia,anemias with bleeding disorders , chronic anemias |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rsf and LHD% |
2 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MC,MRV,MCHC |
2 YEARS |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/10/2013 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Iron status reflects balance between rate of erythropoiesis and iron stores in the body.Iron deficiency is one of the most common nutritional deficiency in world and a leading cause of anemia. Anemia is very common and significant in country like India, Hence early diagnosis is of utmost importance .Anemia is defined as decreased concentration of Hemoglobin(Hb) in the blood, cutoff value depending on age and gender.In practice Anemia is usually diagnosed based on reduction of Hematocrit and Hb concentration ,but isolated Hb measurement has both low specificity and low sensitivity. Several studies in the field of iron metabolism and erythropoiesis are modifying the traditional concepts on anemia. These studies point out the need for reliable diagnostic parameters that allow better evaluation of the causes underlying apparently similar clinical conditions. Thus implying stronger collaboration between laboratory professionals and clinicians in order to optimize early diagnosis of anemia by new analytical parameters viz. RSf (Red cell size factor) and LHD %. |