| CTRI Number |
CTRI/2024/03/064861 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Iron deficiency anemia treatment in adults: comparing daily versus alternate day iron regimens |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy and safety of twice daily versus alternate day oral iron therapy in treatment of mild to moderate iron deficiency anemia in adults - an open label, randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geetha A |
| Designation |
Professor and Head, Department of Pharmacology |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Ground floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru
Department of Pharmacology, Ground floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9886224085 |
| Fax |
|
| Email |
geetha25bmcri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Viswanathan S |
| Designation |
Junior Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Ground floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
8675694258 |
| Fax |
|
| Email |
drviswaa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Viswanathan S |
| Designation |
Junior Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Pharmacology, Ground floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
8675694258 |
| Fax |
|
| Email |
drviswaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Victoria Hospital, OPD building, Krishna Rajendra Market, Bengaluru Urban, Bengaluru 560002 |
|
|
Primary Sponsor
|
| Name |
Viswanathan S |
| Address |
Department of Pharmacology, Ground floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru 560002 |
| 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 |
| Viswanathan S |
Victoria Hospital |
Department of Pharmacology, Ground floor, Bangalore Medical College and Research Institute, Fort, Krishna Rajendra Road, Bengaluru
Bangalore
KARNATAKA |
08675694258
drviswaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute Ethics Committee |
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 |
Ferrous sulphate |
Dose: 200mg, twice daily, oral route, duration: 8 weeks |
| Comparator Agent |
Ferrous sulphate |
Dose: 400mg, once daily on alternate days, oral route, duration: 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to give written informed consent and willing to come for follow-up
2. Adults 18-60 years of age of either sex
3. Patients newly diagnosed as mild to moderate iron deficiency anemia by WHO guidelines |
|
| ExclusionCriteria |
| Details |
1. Patients having comorbidities like chronic kidney disease, chronic liver disease, severe anemia requiring blood transfusion/parenteral iron therapy, cardiac failure patients, gastrointestinal abnormalities, menstrual abnormalities, malignancies and HIV
2. Pregnant and Lactating mothers
3. Patients with clinical or laboratory evidence of other causes of anemia like hemolytic anemias, hemoglobinopathies, gastrointestinal bleed, iron malabsorption, megaloblastic anemia, or anemia of chronic disease
4. Patients with hypersensitivity and intolerance to oral iron supplements.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy is assessed by increase in mean Hemoglobin and serum ferritin levels at the end of 4th week and 8th weeks respectively.
|
0,4,8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety is assessed by monitoring and recording adverse events reported by the patient at any time of the study.
|
4,8 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/04/2024 |
| Date of Study Completion (India) |
31/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
Iron deficiency anemia
(IDA) remains a major public health concern, with oral iron therapy being the
primary treatment. However, gastrointestinal side effects and poor absorption
often lead to non-adherence. Recent evidence suggests that alternate-day iron
dosing may enhance iron absorption while reducing side effects. This study
aimed to compare the efficacy and safety of twice-daily versus alternate-day
oral ferrous sulfate therapy in adults with mild to moderate IDA. The study was conducted
in the General Medicine OPD of a tertiary care hospital from May 2023 to
October 2024. A total of 100 patients diagnosed with IDA were randomly assigned
into two groups in a 1:1 ratio:
- Group A: Received Ferrous sulfate 200
mg twice daily for 8 weeks.
- Group B: Received Ferrous sulfate 400
mg once on alternate days for 8 weeks.
Hemoglobin (Hb) and serum ferritin levels, as well as adverse effects,
were assessed at baseline, 4 weeks, and 8 weeks.
There was a significant
increase in Hb (p<0.001) and ferritin (p<0.001) in both groups.
Additionally, a statistically significant interaction between time and groups
for Hb (p=0.04) and ferritin (p=0.001) was seen. At 8 weeks, Hb increased by
2.52 g/dL in the twice-daily group and 1.91 g/dL in the alternate-day group. Serum
ferritin increased by 29.92 µg/L and 23.41 µg/L, respectively.
Adverse effects were
mostly mild, with nausea and upper gastric discomfort being the most common.
Overall, twice-daily and alternate-day iron therapy are both effective in IDA
treatment. While twice-daily dosing leads to a greater Hb and ferritin rise,
the alternate-day regimen is better tolerated, making it a preferred option for
patients with gastrointestinal intolerance |