| CTRI Number |
CTRI/2023/07/054826 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
05/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Identifying iron deficiency and anemia in babies below 6 months |
|
Scientific Title of Study
|
Prevalence of Iron Deficiency in Early Infancy – A prospective, observational 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 Nisha Bhattacharyya |
| Designation |
Assistant Professor |
| Affiliation |
Ramakrishna Mission Seva Pratishthan, VIMS |
| Address |
Department of Pediatrics
Ramakrishna Mission Seva Pratishthan
99, Sarat Bose Road
Kolkata
27 CIT enclave
27/1C, CIT road
1st Floor
Kolkata 700014
Kolkata
WEST BENGAL
700026
India |
| Phone |
9830054112 |
| Fax |
|
| Email |
nisha_bhattacharyya@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Bhattacharyya |
| Designation |
Assistant Professor |
| Affiliation |
Ramakrishna Mission Seva Pratishthan, VIMS |
| Address |
Department of Pediatrics
Ramakrishna Mission Seva Pratishthan
99, Sarat Bose Road
Kolkata
27 CIT enclave
27/1C, CIT road
1st Floor
Kolkata 700014
Kolkata
WEST BENGAL
700026
India |
| Phone |
9830054112 |
| Fax |
|
| Email |
nisha_bhattacharyya@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Bhattacharyya |
| Designation |
Assistant Professor |
| Affiliation |
Ramakrishna Mission Seva Pratishthan, VIMS |
| Address |
Department of Pediatrics
Ramakrishna Mission Seva Pratishthan
99, Sarat Bose Road
Kolkata
27 CIT enclave
27/1C, CIT road
1st Floor
Kolkata 700014
Kolkata
WEST BENGAL
700026
India |
| Phone |
9830054112 |
| Fax |
|
| Email |
nisha_bhattacharyya@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Ramakrishna Mission Seva Pratishthan, VIMS.
99, Sarat Bose Road
Kolkata 700026 |
|
|
Primary Sponsor
|
| Name |
Ramakrishna Mission Seva Pratishthan |
| Address |
99 Sarat Bose Road
Kolkata-700026 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nisha Bhattacharyya |
Ramakrishna Mission Seva Pratishthan |
Department of Pediatrics
Ramakrishna Mission Seva Pratishthan
99, Sarat Bose Road
Kolkata 700026
Kolkata
WEST BENGAL |
9830054112
nisha_bhattacharyya@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TheInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal newborns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Observational study involving only blood test with clinical examination |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
5.00 Day(s) |
| Gender |
Both |
| Details |
all babies born in RKMSP and either parent cnsenting for blood tests of the baby. |
|
| ExclusionCriteria |
| Details |
Babies born with major congenital malformations, syndromic features or needing NICU admission.
Either parent having Thalassemia |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Iron deficiency & anemia in infants below 6 months of age |
birth to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Finding impact on growth in babies with covert iron deficiency |
birth to 6 months |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
14/07/2023 |
| 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) |
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
|
Hypothesis- Iron deficiency is prevalent in breast fed babies below 6 months and that can have long term implications in terms of growth and brain development. American Academy of Pediatrics recommends Supplementation at $ months age whereas Indian policies recommend iron fortified or rich food after 6 months. We want to find whether American recommendation is justified in our set up or not. |