| CTRI Number |
CTRI/2024/06/068631 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| 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 clinical trial comparing the efficacy of daily dosing vs alternate day dosing of iron sulfate To evaluate the effectiveness of oral Ferrous sulfate 300 mg (60 mg elemental iron) once daily versus every other day to improve hemoglobin at 12 weeks post-initiation in iron deficiency anemia patients. |
|
Scientific Title of Study
|
Daily versus alternate day dosing of oral Ferrous sulphate in patients of iron deficiency anemia A Randomized open label non inferiority 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 |
dr Pankaj Kannauje |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no.413,D block,Aiims Raipur,Tatibandh,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8908493051 |
| Fax |
|
| Email |
drpankajkannauje@aiimsraipur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kannauje |
| Designation |
Assistant Professor |
| Affiliation |
All india Institute of Medical Sciences |
| Address |
Room no.413,D-block,Aiims Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9752696488 |
| Fax |
|
| Email |
drpankajkannauje@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Maninder Routray |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
At-2d3 ward,D-block,Aiims Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8908493051 |
| Fax |
|
| Email |
maninderroutray.mr@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Aiims Raipur |
| Address |
Great Eastern Road,Tatibandh,Raipur,Chhattisgarh,pin-492099 |
| Type of Sponsor |
Government medical college |
|
|
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 MANINDER ROUTRAY |
All India Institute Of medical Sciences,Raipur |
Room no.2D3 ward,Department of General medicine,Dblock,Aiims raipur
Raipur
CHHATTISGARH |
08908493051
maninderroutray.mr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMITEE,ALL INDIA INSTITUTE OF MEDICAL SCIENCES,AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ferrous sulfate |
Dose-300mg
Route-Per Oral
Frequency-Alternate Day
Duration-3months |
| Intervention |
Ferrous Sulfate |
Dose-300mg
Route-Per Oral
Frequency-Once Daily
Duration-3months
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age ≥ 16 years
2.Outpatients with iron deficiency anemia are defined as hemoglobin less than 12.0 g/dL in females or less than 13.0 g/dL in males AND ferritin less than 30 mcg/L
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy and/or currently breastfeeding
2. Known history of inflammatory bowel disease, celiac disease, thalassemia or thalassemia trait, and/or inherited bleeding disorder
3. Known intolerance or lack of response to oral ferrous gluconate, sulfate, or fumarate in the last 12 weeks
4. Multivitamin and mineral supplements (35 mg or more of elemental iron per day) in 2 weeks prior to randomization
5. Allergy to oral iron
6. Allergy to any of the following medicinal and nonmedicinal ingredients in ferrous sulfate: ferrous sulfate, calcium citrate, crospovidone, and talc titanium dioxide
7. Intravenous iron therapy in the past 12 weeks
8. On new anticoagulant therapy initiated in the past 6 months (e.g., warfarin, apixaban, dabigatran, rivaroxaban)
9. Surgery, and/or chemotherapy planned in the upcoming 12 weeks
10. Previously enrolled in the study
11. Creatinine clearance less than 30 mL/min
12. Hemoglobin less than 8.0 g/dL with active bleeding (defined as WHO grade-2 bleeding or higher in the past week
13. Recent blood donation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in hemoglobin from baseline to end of study |
12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in hemoglobin from baseline |
4weeks |
| Proportion of patients showing an increase in hemoglobin >1.5g/dl |
4 weeks |
| 3. Proportion of patients with normal hemoglobin level (>12g/dl or 13g/dl in females and males respectively) |
at the end of the study |
| Incidence of treatment-emergent adverse events (TEAEs) |
end of the study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
10/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The current trial proposes to evaluate the feasibility of performing this study to examine the effectiveness and side effect profile of oral iron once daily vs every other day.Cases will be recruited from pateints comming to general medicine opd with with hb less than 12 in case of female and less than 13 in case of male with serum ferritin less than 30mcg/L.Purpose of this trial is to evaluate the effectiveness of oral Ferrous sulfate 300mg once daily versus every otherday to improve hemoglobin at 12 weeks post-initiation in iron deficiency anemia patients. |