| CTRI Number |
CTRI/2025/12/099431 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effect of daily vs alternate day oral iron therapy for treatment of mild and moderate iron deficiency anemia in children |
|
Scientific Title of Study
|
Daily vs alternate day oral iron therapy for treatment of mild and moderate iron deficiency anemia in children aged 5-18 years: A prospective open-labeled 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 |
Purvi Patel |
| Designation |
Professor |
| Affiliation |
Pramukhswami medical college, Karamsad |
| Address |
Department of pediatrics, H M Patel academic center, gokalnagar, karamsad-388325
Anand
GUJARAT
388325
India |
| Phone |
09825661647 |
| Fax |
|
| Email |
evergreen.purvi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhanshree Vyas |
| Designation |
PG student |
| Affiliation |
Pramukhswami medical college, Karamsad |
| Address |
Department of pediatrics, H M Patel academic center, gokalnagar, karamsad-388325
Anand
GUJARAT
388325
India |
| Phone |
09558170993 |
| Fax |
|
| Email |
dhanshreevyas916@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhanshree Vyas |
| Designation |
PG student |
| Affiliation |
Pramukhswami medical college, Karamsad |
| Address |
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
09558170993 |
| Fax |
|
| Email |
dhanshreevyas916@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree krishna hospital, Gokalnagar, Karamsad-388325, Anand, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dhanshree Vyas |
| Address |
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad |
| 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 Purvi Patel |
Shree krishna hospital |
Pediatric department, H M Patel academic center, shree krishna hospital, Karamsad
Anand
GUJARAT |
09825661647
evergreen.purvi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionethicscommittee-2,Bhaikaka university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E611||Iron deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alternate day iron therapy |
Receive an oral Iron syrup at a dose of 3mg/kg/day as a single morning dose on alternate day for 3 months |
| Comparator Agent |
Daily oral iron therapy |
Receive an oral Iron syrup at a dose of 3mg/kg/day as a single morning dose once daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All Children aged 5 to 18 years having mild or moderate IDA as per WHO guidelines will be included in the study. |
|
| ExclusionCriteria |
| Details |
1.Children having Hb less than 8g/dl i.e. severe anemia as per WHO guidelines
2.Children with anemia other than IDA
3.Children with chronic illness and congenital malformation
4.Patients who are not compliant to oral iron treatment after several reinforcement
5.Patients who are lost to follow up
6.Patients who received blood transfusions within past 3 months
7.Received multivitamin or iron supplement within 2 weeks before randomization.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hematological response after 3 months of oral iron therapy. |
hematological response after 3 months of oral iron therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| occurrence of adverse effects, change in hematological indices, change in iron profile parameters, and compliance to oral iron therapy. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/01/2026 |
| 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 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
|
Iron deficiency anemia (IDA) is a global health problem and the most common cause of anemia worldwide. About half of the world’s cases of anemia are thought to be due to iron deficiency. In the world, approximately 25 % of school age children are anemic. World Health Organization (WHO) defines anemia as a hemoglobin less than 11.5 g/dl and 12 g/dl for children between 5-12years and 12-14 years respectively . Although the definition of anemia is well accepted, the definition of IDA is less standardized. Based on a systematic review conducted to determine the diagnostic value of laboratory tests in the diagnosis of ID, serum ferritin was found to be the most predictive and a better diagnostic test than mean cell volume (MCV) and transferrin saturation (TSAT) To ensure a population with a high likelihood of IDA for this study, ID has been frequently defined as a serum ferritin of less than 15 microgram per liter in children more than 5 years. Oral iron therapy is an inexpensive and effective means of replenishing iron stores in iron deficiency anemia. Traditionally, oral iron salts are taken one or two times a day daily. Recent studies done in population more than 15 years of age suggest that lower doses and alternate day administration may be as effective as the traditional regimen while probably associated with lower rates of adverse effects. In our region, no such studies have been conducted in children with iron deficiency anemia. Therefore, this study is planned for children aged 5 to 12 years with iron deficiency anemia. |