CTRI

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CTRI Number

CTRI/2025/09/095064 [Registered on: 18/09/2025] Trial Registered Prospectively

Last Modified On:

17/09/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparison between daily versus alternate day iron therapy in children with anemia in chronic kidney disease

Scientific Title of Study

Daily versus alternate day dosing of iron therapy for anemia in CKD stage 2-4 in children of age group 2-18 years: An open labelled randomised control trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Aparna K V
Designation	DM senior resident
Affiliation	AIIMS Bhopal
Address	Division of pediatric nephrology Dept of pediatrics AIIMS Bhopal Bhopal MADHYA PRADESH 462020 India
Phone	9400623723
Fax
Email	kvaparna24@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Girish Chandra Bhatt
Designation	Professor
Affiliation	AIIMS Bhopal
Address	Department of Pediatrics AIIMS Bhopal Bhopal MADHYA PRADESH 462020 India
Phone	8642002229
Fax
Email	girish.pediatrics@aiimsbhopal.edu.in

Details of Contact Person
Public Query

Name	Dr Amber Kumar
Designation	Additional Professor
Affiliation	AIIMS Bhopal
Address	Department of Pediatrics AIIMS Bhopal Bhopal MADHYA PRADESH 462020 India
Phone	9555954563
Fax
Email	amber.pediatrics@aiimsbhopal.edu.in

Source of Monetary or Material Support

Department of pediatrics AIIMS Bhopal,Madhya Pradesh,India PIN code:462020

Primary Sponsor

Name	AIIMS Bhopal
Address	AIIMS Bhopal, AIIMS road, Saket Nagar, Habib Ganj, Bhopal 462020
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 Aparna K V	All India Institute of Medical Sciences, Bhopal	Division of pediatric nephrology Department of Pediatrics AIIMS Bhopal,Madhya Pradesh Pin:462020 Bhopal MADHYA PRADESH	9400623723 kvaparna24@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IHEC-SR	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N18\|\|Chronic kidney disease (CKD),

Intervention / Comparator Agent

Type	Name	Details
Intervention	Alternate day iron therapy	alternate day iron therapy(ferrous ascorbate) 6 mg/kg/dose for 3 months
Comparator Agent	Daily iron therapy	Daily iron therapy(ferrous ascorbate) at 3 mg/kg/day for 3 months

Inclusion Criteria

Age From	2.00 Year(s)
Age To	18.00 Year(s)
Gender	Both
Details	1)Children with a diagnosis of anemia in CKD stage G2–4 with Ferritin less than 100 with transferrin saturation less than 40% or if ferritin is between 100-300 and transferrin saturation less than 25%. 2)Hemoglobin of less than 11.5g/dl(5-11 years), less than 12 g/dl(12-14 years), for girls of more than 15 years, hemoglobin less than 12 g/dl and for boys more than 15 years, haemoglobin of less than 13 g/dl.

ExclusionCriteria

Details

1) Current use or use within last 3 months of oral or intravenous iron preparations
2) Associated B12/folate deficiency
3) Blood transfusion within last 3 months
3) Associated hemolytic anemia- Sickle cell, thalassemia
4) Anemia attributed from blood loss(intestinal bleed or bleeding from any other sites)

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To compare increase in transferrin saturation in alternate day iron therapy(6 mg/kg/dose) versus daily oral iron therapy (3 mg/kg/day) in children aged 2-18 years with CKD stage 2-4 over a 12 week period.	3 months

Secondary Outcome

Outcome	TimePoints
To compare the change in hemoglobin between the two groups over the study period	3 months
To assess the incidence and severity of adverse events gastrointestinal side effects (nausea, vomiting, abdominal pain, constipation) between each group.	3 months
To compare adherence between 2 groups	3 months
To compare hepcidin and IL6 level at onset and at 12 weeks between 2 groups	3 months
To correlate between baseline Hb, RBC indices, ferritin, stage of CKD and PTH to response to oral iron therapy	3 months

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
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 4

Date of First Enrollment (India)

01/10/2025

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 - NO

Brief Summary

At first contact with children who fit the inclusion criteria, which include children aged 2 year to 18 years with iron deficiency anemia in CKD defined asper KDIGO 2025 guideline will be screened for the study.After enrollment eligible participants will be randomized in OD: 3 mg/kg/day (control group) or alternate day therapy 6 mg/kg/dose(intervention group) which is given for 3 months. All measurements such as hemoglobin, iron profile studies including transferrin saturation, ferritin, TIBC,and serum iron along with hepcidin and IL6 levels. These are done at baseline and at the end of 12 weeks.