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CTRI Number  CTRI/2025/10/095803 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 27/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Preliminary Study Comparing Single Iron Injection with Daily Oral Iron in Children (7-18 years) with Severe Anemia 
Scientific Title of Study   Comparative Efficacy and Safety of Single-Dose Intravenous Ferric Carboxymaltose vs Standard Oral Ferrous Iron for Children Aged 7 to 18 Years with Severe Iron Deficiency Anemia An Open Label Parallel Group Pilot Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Onkar Laxman Daware 
Designation  Junior resident  
Affiliation  AIIMS BIBINAGAR 
Address  Room no 17 Department of paediatrics All India Institute of Medical Sciences Bibinagar Bibinagar Mandal Yadadri Bhuvanagiri District Telangana India

Nalgonda
TELANGANA
508126
India 
Phone  8788353183  
Fax    
Email  onkardaware11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mounika Reddy 
Designation  Associate Professor 
Affiliation  AIIMS BIBINAGAR 
Address  Room No. 17, Department of Paediatrics, All India Institute of Medical Sciences, Bibinagar, Bibinagar Mandal, Yadadri Bhuvanagiri District, Telangana, India

Nalgonda
TELANGANA
508126
India 
Phone  9855784739  
Fax    
Email  doc.mounikareddy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Onkar Laxman Daware 
Designation  Junior resident  
Affiliation  AIIMS BIBINAGAR 
Address  Room no 17 Department of paediatrics All India Institute of Medical Sciences Bibinagar Bibinagar MandalYadadri Bhuvanagiri District, Telangana, India

Nalgonda
TELANGANA
508126
India 
Phone  8788353183  
Fax    
Email  onkardaware11@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Mounika Reddy 
Address  Room No 17, Department of Pediatrics, AIIMS Bibinagar Warangal highway, Yadadri Bhongir district, Telangana - 508126. Ph No - 9855784739, Email: doc.mounikareddy@gmail.com 
Type of Sponsor  Other [Chief guide/supervisor] 
 
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 Onkar Laxman Daware  All India Institute Of Medical Sciences, Bibinagar  Department of Pediatrics, 4th Floor, C and F Block, All India Institute of Medical Sciences, Bibinagar, Bibinagar Mandal, Warangal highway, Yadadri Bhuvanagiri District, Telangana, India - 508126
Nalgonda
TELANGANA 		 8788353183

onkardaware11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BBN-IEC  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  Intravenous ferric carboxymaltose (FCM)  The intervention arm will receive intravenous ferric carboxymaltose (FCM), administered as a single dose of 15 mg/kg (up to a maximum of 1000 mg), diluted in 0.9% sodium chloride in a 5:1 ratio, and infused over 15–20 minutes as a day-care procedure with short elective admission. No test dose or premedication will be required. Post-infusion, participants will be monitored for at least three hours to observe for any adverse reactions. Emergency equipment and trained personnel will be available during the infusion, and all standard procedures, nursing care, and adverse event monitoring protocols will be strictly followed. 
Comparator Agent  Oral ferrous sulphate or ferrous fumarate   The control group will receive oral ferrous sulphate or ferrous fumarate at a dose of 3 mg/kg/day of elemental iron, administered once daily at bedtime (1–2 hours after dinner) for three months, in either syrup or tablet form. Doses will be rounded to the nearest 5 mg (syrup) or 10 mg (tablet) and dispensed monthly. Caregivers will be instructed not to administer other iron-containing products or mix the study medication with food or liquids, particularly milk, within one hour of dosing. Re-dosing will not be permitted if the child spits out the medication; however, a new dose may be given if the medication is spilled before ingestion. Caregivers will receive training on proper administration techniques and will maintain a daily treatment diary documenting medication intake and adverse effects, to be submitted at follow-up visits. Weekly SMS reminders will be sent to reinforce adherence and follow-up attendance. Adherence will be monitored through caregiver diaries, returned medication volumes, and pill counts at monthly visits. In accordance with standard clinical practice, iron therapy will be temporarily withheld during acute illness. Oral iron will continue for a total of 12 weeks, regardless of the time to hemoglobin normalization, to ensure adequate iron store repletion. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 7 to 18 years with a confirmed diagnosis of severe iron deficiency anemia, based on hematological parameters
Written informed consent obtained from parents or legal guardians along with assent from the child, as appropriate.
Willing to complete the study procedures and follow-up visits as per protocol
 
 
ExclusionCriteria 
Details  1. Anemia of non-iron deficiency etiology hemoglobinopathies, bone marrow failure, chronic disease, etc
2. Concomitant B12 - less than 200 pg/mL or folate deficiency - serum folate less than 4 ng/mL anemia
3. Chronic kidney disease or chronic liver disease
4. Documented or suspected conditions causing significant intestinal malabsorption e.g., untreated celiac disease, inflammatory bowel disease, chronic diarrhea, short bowel syndrome
5. Ongoing clinically significant blood loss requiring active medical or surgical intervention e.g. uncontrolled gastrointestinal bleeding, hematuria, or gynecological bleeding requiring treatment. Stable, chronic menorrhagia will be included.
6. Neurological conditions affecting feeding, swallowing, or compliance e.g., cerebral palsy with feeding difficulties
7. Receipt of therapeutic iron or blood transfusion in the past 4 weeks to avoid confounding effects on hemoglobin and iron status response.
8. Immediate indication for packed red blood cell transfusion
9. Known allergy or hypersensitivity to intravenous or oral iron preparations.
10. Participation in another clinical trial.
11. Known or suspected pregnancy
12. Known hepatitis B or C or HIV infection - due to ongoing chronic inflammation

Presence of any medical condition deemed to interfere with participation or adherence to the protocol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in peripheral blood hemoglobin (g/dL) concentration from baseline to 4 weeks post-enrolment  Baseline to 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in hemoglobin and ferritin at 2, 4, 8, and 12 weeks  2, 4, 8, 12 weeks 
Proportion of participants with adverse events and SAEs  Baseline to 12 weeks 
Change in health-related quality of life and fatigue scores from baseline to 12 weeks  Baseline & 12 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   07/11/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [doc.mounikareddy@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Iron deficiency anemia is one of the most common health problems affecting children in India and around the world. It can make children feel tired, weak, and less able to concentrate at school or play normally. While doctors usually treat this condition with daily iron tablets or syrup, many children do not take the medicine regularly because of stomach upset, bad taste, or forgetfulness. Some children also do not improve well with oral iron. A newer form of treatment involves giving iron through a single injection into the vein, which might correct the anemia faster and improve the child’s energy and health with fewer side effects.
This study will compare the usual oral iron treatment with a single dose of intravenous (IV) ferric carboxymaltose (a type of injectable iron) in children aged 7 to 18 years who have severe iron deficiency anemia. The study will be done at AIIMS Bibinagar and will include 50 children. Half of the children will receive the standard iron syrup or tablets every day for three months. The other half will get one dose of IV iron in a hospital setting. All children will be followed closely for three months to monitor improvement in hemoglobin (the part of blood that carries oxygen), side effects, and overall health and well-being.
The researchers will check how well each treatment works by measuring how much the hemoglobin level increases after 4 weeks. They will also look at how much better the children feel, whether the treatment was easy to give and take, and whether there were any side effects. Parents will be asked about their experience and whether they would prefer this type of treatment for their child in the future.
Children and their families will receive proper instructions on how to take the medication, and regular check-ins will be done to remind them and answer any concerns. Blood tests will be done at specific time points to track the response to treatment. If any child becomes unwell during the study, appropriate care will be provided, and any serious problems will be reviewed by an independent safety team. The study will follow strict ethical rules, and the families can stop participation at any time without affecting the child’s medical care.
This is the first study in this region to explore whether a single IV iron dose is a better option than daily iron medication for children. If successful, it could offer an easier and more effective way to treat iron deficiency anemia in children, especially those who have difficulty taking daily medicine. The results may help change how doctors treat this condition and improve the quality of life for children suffering from anemia.
 
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