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CTRI Number  CTRI/2021/01/030837 [Registered on: 29/01/2021] Trial Registered Prospectively
Last Modified On: 27/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Serum iron profile in anemias 
Scientific Title of Study   Serum iron profile and bone marrow iron stores in iron deficiency anemia and anemia of chronic disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Yadav 
Designation  Junior resident 
Affiliation  Rohilkhand medical college, Bareilly 
Address  G block Rohilkhand medical college, Bareilly
Department of Pathology, Rohilkhand medical college, Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  8572905005  
Fax    
Email  ay2566801@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nitesh Mohan 
Designation  Professor 
Affiliation  Rohilkhand medical college, Bareilly 
Address  Department of Pathology, Rohilkhand medical college, Bareilly , U P
Department of Pathology, Rohilkhand medical college, Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  9997872559  
Fax    
Email  drnitesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anjali Yadav 
Designation  Junior resident 
Affiliation  Rohilkhand medical college, Bareilly 
Address  G block Rohilkhand medical college, Bareilly
Department of pathology , Rohilkhand medical college,Bareilly
Bareilly
UTTAR PRADESH
243006
India 
Phone  8572905005  
Fax    
Email  ay2566801@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College, Bareilly. 
 
Primary Sponsor  
Name  Rmch bareilly 
Address  G block Rmch bareilly UP 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anjali Yadav  Rohilkhand medical college  Department of Pathology
Bareilly
UTTAR PRADESH 		 8572905005

ay2566801@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee rmch bareilly   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients coming to OPD with clinical signs and symptoms of anemia having hemoglobin < 11 gm/dl  
 
ExclusionCriteria 
Details  1.Patients having hemoglobin > 11 gm/dl .
2. Patient already on treatment of anemia.
3. Patient having bleeding diathesis. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Comparison of serum iron profile and bone marrow iron stores in cases of iron deficiency anemia and anemia of chronic diseases in patients diagnosed with iron deficiency anemia.  NIL 
 
Secondary Outcome  
Outcome  TimePoints 
Determination of prevalence of iron deficiency anemia and anemia of chronic diseases in patients attending medical OPD during study period.  NIL 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   31/01/2021 
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   NIL  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ay2566801@gmail.com].

  6. For how long will this data be available start date provided 30-07-2022 and end date provided 30-12-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

•        Anemia is not a disease, but a manifestation of many underlying disease. It is a common problem in   clinical practice.
•         Anemia is defined as a reduction of the total circulating red cell mass below normal limits.[1]
•        Among various types of anemia, Iron deficiency anemia is the most common  nutritional deficiency seen in India. Routine screening as well as specific tests are done to diagnose anemia.
•        Bone marrow examination is becoming highly important for diagnosis and therapeutic indication of several haematological and other illnesses.[2] Gold standard examination is Bone marrow Microsopy in these conditions.
•        Bone marrow aspiration and trephine biopsies are to aid cytological,  immunophenotypical and molecular genetic . This study propounds the serum iron profile and bone marrow iron stores as diagnostic tool to find out whether these biochemical assays can help to correlate the dynamics of metabolic reactions in the conditions and to further assess the role of morphological grading of iron stores in bone marrow aspiration and trephine biopsies in cases of anemia.

 
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