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CTRI Number  CTRI/2024/05/066760 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two oral iron preparations for treatment of iron deficiency anemia in children 
Scientific Title of Study   Ferrous Ascorbate Vs Ferrous Sulphate for the Treatment of Iron Deficiency Anemia in Children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aarushi Kharb 
Designation  Post-graduate student in the Department of Pediatrics of University College of Medical Sciences 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur Hospital  
Address  Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-110095

North East
DELHI
110095
India 
Phone  8373046043  
Fax    
Email  1997aashi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Pooja Dewan 
Designation  Director Professor, Department of Pediatrics  
Affiliation  University College of Medical Sciences and Guru Teg Bahadur Hospital 
Address  Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-110095

North East
DELHI
110095
India 
Phone  8373046043  
Fax    
Email  1997aashi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aarushi Kharb 
Designation  Post-graduate student in the Department of Pediatrics of University College of Medical Sciences 
Affiliation  University College of Medical Sciences and Guru Teg Bahadur Hospital  
Address  Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-110095

North East
DELHI
110095
India 
Phone  8373046043  
Fax    
Email  1997aashi@gmail.com  
 
Source of Monetary or Material Support  
Intra-Mural Research Grant by University College of Medical Sciences 
 
Primary Sponsor  
Name  Intra-Mural Research Grant by University College of Medical Sciences 
Address  Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-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 
Dr Aarushi Kharb  Department of Pediatrics, UCMS and GTB Hospital  Department of Pediatrics,UCMS and GTB Hospital, Dilshad Garden, Delhi-110095
North East
DELHI 		 8373046043

1997aashi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Human Research (IEC-HR)  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 
Intervention  Ferrous Ascorbate  Each participant will be given liquid formulation of ferrous ascorbate at 3mg/kg of elemental iron daily for total 3 months 
Comparator Agent  Ferrous Sulphate  Each participant will be given liquid formulation of ferrous ascorbate at 3mg/kg of elemental iron daily for total 3 months 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Iron deficiency anemia will be defined as hemoglobin less than 11 g/dL and categorized as per WHO definition with peripheral blood smear suggestive of microcytic hypochromic picture AND low mean corpuscular volume and low serum ferritin
below 12 mcg/L in the absence of infection and below 30 mcg/L in the presence of infection  
 
ExclusionCriteria 
Details  Children with anemia due to dimorphic or megalobastic blood picture in peripheral smear or apparent non-nutritional etiology of anemia (obvious bleeding or chronic hemolytic anemia or malignancies) or known or suspected chronic systemic disease or those who have received iron preparations during last 2 weeks or those who received blood/packed cell transfusion within last 3 months will be excluded 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of non-anemic children after 12 weeks of therapy  12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of participants compliant to oral iron therapy in the two groups
2. Side effects experienced among the two groups.
3. Proportion of children having appetite recovery using 16-item “Early Childhood Appetite and Satiety Tool (ECAST)” at 1, 2 and 4 weeks.
4. Hb at baseline, 2, 8 and 12 weeks of therapy.
5. Serum ferritin level at baseline and week 12.
 		 1, 2, 4, 8, 12 weeks 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/05/2025 
Date of Study Completion (India) 23/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Title: Ferrous Ascorbate Vs Ferrous Sulphate for the Treatment of Iron Deficiency Anemia in Children.

Aim: To compare the efficacy and acceptability of ferrous ascorbate and ferrous sulphate in the treatment of iron deficiency anemia in children (6 months – 5 year).

Objectives

Primary:

To compare the efficacy of daily oral iron supplementation using ferrous ascorbate or ferrous sulphate in children aged 6mo-5y with ID anemia (Hb < 11g/dL) in terms of proportion of non-anemic children after 12 weeks of therapy.

Secondary:

To compare the two groups with respect to 

1.     Acceptability in terms of compliance to oral iron therapy and side effects experienced

2.      Improvement in appetite ascertained using Hindi version of 16-item “Early Childhood Appetite and Satiety Tool (ECAST)” on 1, 2 and 4 weeks

3.     Rise in hemoglobin (Hb) after 2, 8 and 12 weeks of therapy

4.     Proportion of non-anemic children at 8 weeks of therapy

5.     Change in ferritin level at 12 weeks of therapy

Study Setting: Department of Pediatrics, Pathology and Biochemistry, UCMS and GTB Hospital, Delhi.

Study Design: Open label, stratified randomized, permuted block design

Study Duration: April 2024 – August 2025

Ethics: Approval will be obtained from the Institutional Ethics Committee for Human Research.  

Consent: Written informed consent will be taken from the parents/caregivers of the enrolled participants. 

Trial Registry: The trial will be registered in the Clinical Trial Registry of India (CTRI).

Participants: Children aged 6 months to 5 years with anemia (Hb < 11g/dL) with iron deficiency (serum ferritin < 12 mcg/L or <30 mcg/L in the presence of infection) will be included. Children with anemia having a dimorphic or megalobastic peripheral blood smear, apparent non-nutritional etiology of anemia (obvious bleeding, chronic hemolytic anemia, malignancies), known or suspected chronic systemic disease, those who have received iron preparations during last 2 weeks or those who received blood/packed cell transfusion within last 3 months, will be excluded.

Intervention: Baseline complete blood count (CBC) and serum ferritin levels will be assessed using 4 ml venous sample. Iron deficient anemic children will be divided into strata:Hb <7 g/dL, Hb 7-9.9 g/dL, Hb 10-10.9 g/dL. Equal number of participants in each strata will be randomized into either of the intervention strategies using computer generated block randomization technique. Allocation concealment will be done using sequentially numbered sealed opaque envelopes. Participants will receive oral iron (elemental iron dose 3 mg/kg) either as ferrous ascorbate or ferrous sulphate administered as a single daily dose for 12 weeks duration. Participants will be followed up on week 1,2 ,4 8 and 12 and details regarding compliance and adverse effects will be assessed. Compliance will be considered good if adherence to medication is 90% of the prescribed doses. CBC will be assessed after 2, 8 and 12 weeks using 1 ml venous blood. CBC and serum ferritin will be estimated at 12 weeks using 4 ml peripheral venous blood sample. Appetite of children will be assessed during hospital follow up visits or through telecommunication at week 1, 2, 4 using 16-item “Early Childhood Appetite and Satiety Tool (ECAST)”, translated in Hindi.

Sample Size: Sample size was calculated using online sample size calculator (www.sealedenvelope.com) assuming a non-inferiority trial design. If there is a true difference in favour of the experimental treatment (Ascorbate) of 10% (95% vs 85%), then total of 98 patients are required, with power of the study being 80%, the upper limit of a one-sided 95% confidence interval and type I error being 5%. Assuming attrition rate of 10%, we will recruit 55 participants per group.

Outcome Variables

Primary Outcome Variable: Proportion of non-anemic children after 12 weeks of therapy

Secondary Outcome Variables  

1.     Proportion of participants compliant to oral iron therapy in the two groups

2.     Side effects experienced among the two groups

3.     Proportion of children having appetite recovery using 16-item “Early Childhood Appetite and Satiety Tool (ECAST)” at 1, 2 and 4 weeks

4.     Hb at baseline, 2, 8 and 12 weeks of therapy

5.     Serum ferritin level at baseline and week 12

Statistical analysis: Collected data will be entered in the excel sheet and will be analyzed using SPSS software. Categorical variables including proportion of anemic children at after 2, 8 and 12 weeks in both groups will be analyzed using Chi-square test. Serum hemoglobin levels, serum ferritin levels, ECAST score, compliance rate and frequency of side effects will be compared between two groups by t-test / Mann-Whitney test. Change in Hb and serum ferritin within the groups will be tested by paired t-test or Wilcoxon signed rank test. Intention to treat analysis as well as per protocol analysis will be done for primary variable. For patients who are lost to follow up after 4 weeks, their Hb values at 4 weeks will be used for analysis of primary outcome. Level of significance will be P value <0.05.

 
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