| CTRI Number |
CTRI/2025/07/091237 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Daily vs Alternate Day Iron Doses in Children with Iron Deficiency Anemia: Which Works Better? |
|
Scientific Title of Study
|
Comparison of Conventional Daily Iron Therapy vs Alternate Day Iron Therapy in Children with Iron Deficiency Anemia: A Randomized Controlled 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 |
Ohm Ashwin M |
| Designation |
Post Graduate |
| Affiliation |
Thanjavur Medical College |
| Address |
Department of Paediatrics,
Government Rajamirasdar Hospital,
Thanjavur Medical college, Thanjavur
Thanjavur
TAMIL NADU
613001
India |
| Phone |
8190896652 |
| Fax |
|
| Email |
mohmram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Selvakumar |
| Designation |
Head of the Department |
| Affiliation |
Thanjavur Medical College |
| Address |
Department of Paediatrics,
Government Rajamirasdar Hospital,
Thanjavur
Thanjavur
TAMIL NADU
613001
India |
| Phone |
9842452437 |
| Fax |
|
| Email |
drselva_kumar69@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ohm Ashwin M |
| Designation |
Post Graduate |
| Affiliation |
Thanjavur Medical College |
| Address |
Department of Paediatrics,
Government Rajamirasdar Hospital,
Thanjavur Medical college, Thanjavur
Thanjavur
TAMIL NADU
613001
India |
| Phone |
8190896652 |
| Fax |
|
| Email |
mohmram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Rajamirasdar Hospital,
Thanjavur Medical college, Thanjavur, Tamilnadu, India - 613001 |
|
|
Primary Sponsor
|
| Name |
Ohm Ashwin M |
| Address |
Room no.34, Cholan Hostel, Thanjavur Medical college, Thanjavur- 613004 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ohm Ashwin M |
Government Rajamirasdar Hospital |
Ward no.500, 119
Department of Paediatrics
Thanjavur
TAMIL NADU |
8190896652
mohmram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thanjavur Medical College Institutional Ethical Committee for Human Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Supplementation of Daily Iron in Iron deficiency anemia Children |
Supplementing Iron in Ferrous Ascorbate formulation Syrup daily like conventional therapy to Iron Deficiency Anemia Children for 3 months |
| Intervention |
Supplementation of Iron in alternate days in Iron deficiency anemia Children |
Supplementing Iron in Ferrous Ascorbate formulation Syrup in alternate days to Iron Deficiency Anemia Children for 3 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3 years to 12 years
patients with Iron Deficiency Anemia defined by
Hb less than 10 mg/dL
Peripheral smear showing microcytic hypochromic blood picture And or
Serum Ferritin less than12 micro gm/L in children less than 5 years and less than 15 micro gm/L in children more than 5 years.
|
|
| ExclusionCriteria |
| Details |
Allergy to oral iron
- Known history of inflammatory bowel disease, celiac disease, thalassemia or thalassemia trait
- Known case of any bleeding disorder
- Known intolerance or lack of response to oral ferrous iron forms
- Intravenous iron therapy in the past 12 weeks
- Children with Chronic Kidney Disease, Chronic Liver Disease, Cardiac Failure, Concomitant Malignancy, Hemolytic Anemias ( including hemoglobinopathies )
- Surgery, chemotherapy or blood donation planned in upcoming 12 weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy & safety of alternate day oral iron therapy with daily oral iron therapy in children with Iron deficiency Anemia |
At Baseline, at the end of 4th week, 8th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing the increase in Hemoglobin, Mean Corpuscular Volume, Mean Corpuscular Haemoglobin in both groups |
At Baseline, at the end of 4th week, 8th week aand 12th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="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
|
- This study aims to investigate whether alternate-day iron supplementation could be as effective as daily supplementation while potentially reducing side effects and improving compliance.
- Children with Iron Deficiency Anemia are screened.
- After Screening and Eligibility assessment , Informed Written Consent will be obtained. Complete baseline assessments are done and participants are subjected to Randomization
- Randomization are done in 1:1 ratio to daily or alternate day oral iron supplementation by Computer based Randomization
- Dosage of 4 mg/kg/day of elemental iron is prescribed in Syrup form ( Syrup containing Ferrous Ascorbate supplemented with Folic acid ) uniformly to all the study participants.
- Follow-up assessments are done on Day 28, 56 and 84
- Parameters assessed: Hemoglobin, Mean Corpuscular Volume, Mean Corpuscular Haemoglobin
|