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CTRI Number  CTRI/2024/01/061216 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 27/12/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Iron deficiency in sickle cell disease  
Scientific Title of Study   Assessment of iron deficiency anemia and role of iron therapy in sickle cell disease patients: A prospective 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. Anand Bodade 
Designation  Scientist-E (Medical) 
Affiliation  ICMR CRMCH  
Address  ICMR-Centre for Research, Management and Control of hemoglobinopathies, Padoli, Opposite Narayana Vidyalam, Chandrapur
ICMR CRCMH Chandrapur under ICMR NIIH Parel Mumbai
Chandrapur
MAHARASHTRA
442406
India 
Phone  08080889764  
Fax    
Email  anandbodade5@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ANAND BODADE 
Designation  Scientist E (Medical) 
Affiliation  ICMR CRMCH under ICMR NIIH  
Address  ICMR CRMCH, Padoli, Opposite Narayan Vidyalayam, Chandrapur
ICMR CRMCH Chandrapur under ICMR NIIH Mumbai
Chandrapur
MAHARASHTRA
442406
India 
Phone  08080889764  
Fax    
Email  anandbodade5@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Anand Bodade 
Designation  Scientist-E (Medical) 
Affiliation  ICMR CRMCH under ICMR NIIH  
Address  ICMR CRMCH Chandrapur Padoli Opposite Narayana Vidyalam Chandrapur
ICMR CRMCH Chandrapur under ICMR NIIH Mumbai
Chandrapur
MAHARASHTRA
442406
India 
Phone  08080889764  
Fax    
Email  anandbodade5@rediffmail.com  
 
Source of Monetary or Material Support  
ICMR (Intramural/ research grant) 
 
Primary Sponsor  
Name  ICMR 
Address  ICMR New Delhi 
Type of Sponsor  Research institution 
 
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 
Dr Anand Bodade  ICMR-Centre for Research, Management and Control of hemoglobinopathies, Chandrapur  ICMR-Centre for Research, Management and Control of Haemoglobinopathies Opposite Narayan Vidyalaya, Padoli, Chandrapur, Maharashtra 442406
Chandrapur
MAHARASHTRA 
08080889764

anandbodade5@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICMR CRMCH, Chandrapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D571||Sickle-cell disease without crisis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects in steady state, i.e. absence of clinical features of acute illness for at least 4 weeks prior to recruitment
2. Confirmed for SCD-HbSS based on HPLC reports and molecular analysis
3. Clinically having complaints of anemia (fatigue, weakness, lethargy, poor appetite, pica, reduced development and physical performance) and not having any symptoms but HbSS
4. Those on Hydroxyurea (HU)
 
 
ExclusionCriteria 
Details  1. Received iron supplements < 3 months prior to recruitment
2. H/o BTx in < 3 months prior recruitment, H/o repeated transfusion ≥ 5 units
3. Severe anemia Hb< 7gm/dL
4. Patients on iron chelation therapy, patients in acute crises
5. Other diagnosed hemolytic diseases: thalassemia, G6PD deficiency, malaria, dengue
6. Raised CRP (> 5 mg/l), liver disease, clinically suspected hepatic disease
7. Diagnosed malignancy
8. Another micronutrient deficiency viz B12, folate/B9
9. Denial of consent
10. Non-compliant to Iron therapy
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Iron deficiency in SCD patients based on hematological parameters and surrogate markers will be done and improvement in Hb levels by at least 2gm/dL at the end of therapy; observed after 3 months and 6 months of daily dose.  Assessment of Iron deficiency in SCD patients based on hematological parameters and surrogate markers will be done and improvement in Hb levels by at least 2gm/dL at the end of therapy; observed after 3 months and 6 months of daily dose. 
 
Secondary Outcome  
Outcome  TimePoints 
Effects of this iron therapy in clinical features viz, no pain crisis episodes, VOCs, c/o fatigue, hemolysis episodes and jaundice at end of therapy. And those achieving normal iron indices such as sr. iron, sr. ferritin, TIBC, and TS and MCV, MCH, MCHC.
Any adverse effects of iron therapy will be monitored.
 
initially monthly and then 3 months and 6 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   15/01/2024 
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="3"
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  

IDA in SCD is multifactorial resulting from ongoing haemolysis, chronic inflammation and micronutrient deficiency. It is presumed that IDA is uncommon in SCD because of recirculation of iron from ongoing hemolysis and blood transfusions patients receive. Various studies mentioned its significant prevalence from 28-67%. Recent study in SCD-pregnant women from Orrisa revealed high/elevated iron stores in them. Diagnosing IDA in SCD is challenging due to elevated ferritin levels and coinheritance of α-thalassemia causing hypochromic-microcytosis. So, IDA can often go unnoticed/underdiagnosed. Murine models showed iron-restricted diet helped in reducing crisis-episodes with potential benefit in reducing organ damages. Thus, some important clinical questions remain to be answered for optimum management of IDA viz. appropriate diagnosis and role of iron therapy.

Novelty:

1. Exact prevalence of IDA in Indian SCD will be calculated after correct diagnosis.

2. Role of iron therapy will be established as many clinicians avoid it in fear of toxicity.

Objectives:

1. To measure prevalence of IDA in SCD

2. To corelate clinical features and complications in SCD patients with their iron status

3. To understand effect of iron therapy on clinical manifestations and Hb-levels in SCD patients with IDA

Methods:

It will be a prospective study. Using various laboratory investigations correct estimate of IDA in Indian SCD will be calculated and diagnosed patients will be prescribed oral iron therapy and followed up for response.

Expected outcome:

1. Exact prevalence of IDA in Indian SCD will be calculated.

2. Role of various laboratory investigations for correct diagnosis will be proposed.

3. Early diagnosis and interventions will help to combat deleterious complications of anemia.

 
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