| 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
|
|
|
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
|
|
|
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. |