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CTRI Number  CTRI/2025/05/087146 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of iron deficiency in 3.5 month infants in a tertiary care teaching hospital 
Scientific Title of Study   Prevalence of iron deficiency in 3.5 month infants in a tertiary care teaching hospital: A Cross sectional 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  Nikita Kumari  
Designation  Post graduate student 
Affiliation  University college of medical sciences and GTB hospital 
Address  Department of paediatrics,6th floor, MCH building , UCMS and GTB hospital
Dilshad garden,new delhi
East
DELHI
110095
India 
Phone  7982815038  
Fax    
Email  nikitachaudhary1503@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Sachan 
Designation  Associate Professor  
Affiliation  UCMS and GTB Hospital  
Address  Department of paediatrics,UCMS and GTB hospital,new delhi
Dilshad garden ,new delhi
East
DELHI
110095
India 
Phone  7839100100  
Fax    
Email  drravisachangtbh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nikita Kumari 
Designation  Postgraduate student 
Affiliation  UCMS and GTBH 
Address  Department of paediatrics,6th floor,MCH building,UCMS and GTB hospital
Dilshad garden,new delhi
East
DELHI
110095
India 
Phone  7982815038  
Fax    
Email  nikitachaudhary1503@gmail.com  
 
Source of Monetary or Material Support  
UCMS and GTB hospital,dilshad garden,New delhi -110095 
 
Primary Sponsor  
Name  Intramural Research GrantUniversity college of medical sciences  
Address  Ucms and GTB hospital,Dilshad garden, new delhi ,india-110095 
Type of Sponsor  Government 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 
Nikita kumari  GTB hospital   Department of paediatrics,GTB hospital and UCMS,new delhi
East
DELHI 		 7982815038

nikitachaudhary1503@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research,UCMS,new delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  3.50 Month(s)
Age To  4.00 Month(s)
Gender  Both 
Details  Born at term gestation, 3.5 - 4 month infants 
 
ExclusionCriteria 
Details  history of any acute illness requiring hospitalization for more
than a week, any chronic systemic illness, any history of blood transfusion, history of iron
supplementation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of infants having Serum Ferritin less than 12 micrograms/L at
3 and half months of age 		 14 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of infants having Hemoglobin (Hb) less than 10.5 g/dL
and serum ferritin less than 12 micrograms/L at 3 and half months of age 		 3 and half to 4 months of age 
 
Target Sample Size   Total Sample Size="258"
Sample Size from India="258" 
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)   31/05/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
STUDY TITLE: Prevalence of iron deficiency in 3.5 month infants in a tertiary care
teaching hospital: A Cross Sectional Study
RATIONALE: Prevalence of iron deficiency has been increasing despite iron supplementation
programs. Iron deficiency has been associated with adverse effects on neuro-development, low
IQ and anemia. Therefore, there is an urgent need for assessing the iron status in young infants
and re-considering the age for initiating iron supplementation.
AIM: To estimate the prevalence of iron deficiency in infants at 3.5 months of age.
OBJECTIVES: Primary: To estimate the proportion of infants at age 3.5 having iron
deficiency (Serum Ferritin <12 micrograms/L) in an immunization clinic; Secondary : To
estimate the proportion of infants at age 3.5 months having iron deficiency anemia (Hb<10.5
g/dL and serum ferritin <12 micrograms/L) in an immunisation clinic.
STUDY SETTING: Immunisation clinic, Department of Paediatrics and Department of
Pathology, UCMS & GTB Hospital, Delhi.
STUDY DESIGN: Cross Sectional Study .
TIME FRAME: April 2024-August 2025
ETHICS: Study will be conducted after approval from Institutional Ethics Committee for
Human Research. Informed written consent will be obtained from parents or guardians.
SAMPLE SIZE: Considering the prevalence of iron deficiency anemia at 3.5 months as
21.4% with margin of error 5%, with 95% confidence interval, at α=5%, a sample size of 258
infants of 3.5 months age is required.
PARTICIPANTS: Inclusion criteria: born at term (37 to 42 weeks gestation), aged 3.5-4
months; Exclusion Criteria: history of any acute illness requiring hospitalization for more
than a week, any chronic systemic illness, any history of blood transfusion, history of iron
supplementation.
METHODOLOGY: All term infants of age 3.5 months attending immunization clinic will
be recruited after written informed consent from parents or guardians. Venous blood samples
will be taken and CBC and serum ferritin will be measured. Participants will be considered to
have Iron deficiency if serum ferritin <12 micrograms/L and Iron deficiency anemia if
hemoglobin <10.5 g/dl and serum ferritin <12 mcg/L.
OUTCOMES: Primary: Proportion of infants having Serum Ferritin <12 micrograms/L at
3.5 months of age; Secondary: Proportion of infants having Hemoglobin (Hb) <10.5 g/dL
and serum ferritin <12 micrograms/L at 3.5 months of age.
STATISTICAL ANALYSIS: Data will be entered in MS Excel sheet and outcome measures
will be reported as proportions.
 
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