| CTRI Number |
CTRI/2025/07/091080 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying the effectiveness of Iron Supplementation in women with Iron Deficiency Anemia |
|
Scientific Title of Study
|
Effectiveness of Iron Supplementation on Consecutive Day versus Alternate Day in women with Iron Deficiency Anemia-A Randomized Comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manikandan S |
| Designation |
PG student |
| Affiliation |
SRM College of Pharmacy |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy ,SRMIST, Kattankulathur, Chengalpattu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
|
| Fax |
|
| Email |
drmanikandan.in.pharma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S Sarumathy |
| Designation |
Assossiate professor |
| Affiliation |
SRM College of Pharmacy |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy ,SRMIST, Kattankulathur, Chengalpattu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
|
| Fax |
|
| Email |
sarumats@srmist.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Manikandan S |
| Designation |
PG student |
| Affiliation |
|
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy ,SRMIST, Kattankulathur, Chengalpattu
Kancheepuram TAMIL NADU 603203 India |
| Phone |
|
| Fax |
|
| Email |
drmanikandan.in.pharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Pharmacy, SRMIST, Kattankulathur, Chengalpattu, Tamil Nadu- 603203 |
|
|
Primary Sponsor
|
| Name |
SRM college of pharmacy |
| Address |
Department of pharmacy practice,SRM College of pharmacy ,SRMIST,Kattankulathur,chengalpattu |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tamil Nadu Pharmaceutical Sciences Welfare Trust |
Tamil Nadu Pharmaceutical Sciences Welfare Trust, 608A, 6th Floor, Phase I, Spencer Plaza, 768/769, Anna Salai, Chennai- 600002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MANIKANDAN S |
SRM Medical College Hospital and Research Centre |
Department of Obstetrics and Gynecology, SRM Medical College Hospital and Research Centre, Kattankulathur, Chengalpattu Kancheepuram TAMIL NADU |
8940229574
drmanikandan.in.pharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
| Intervention |
Ferrous Fumarate 156 mg OD with Folic Acid 1500 mcg OD |
Group A- Consecutive day administered with Ferrous fumarate 156mg OD and Folic acid 1500 mcg OD,
Group B Alternate day administered with Ferrous fumarate 156mg OD and Folic acid 1500 mcg OD
|
| Comparator Agent |
Folic acid 1500 mcg OD |
Group A- Consecutive day administered with Ferrous fumarate 156mg OD and Folic acid 1500 mcg OD,
Group B Alternate day administered with Ferrous fumarate 156mg OD and Folic acid 1500 mcg OD
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
➢Healthy women aged between 18-45 years with depleted iron stores (serum ferritin 25 ug/L or less) and haemoglobin levels (7-10.9 g/dl).
➢ Women with normal Body mass index (since overweight or obese women
have sub clinical inflammation)
➢ Should not have donated blood or plasma donations in previous 4 months.
➢ Should not be on any medications that may interfere with iron absorption
within two weeks of the study start.
|
|
| ExclusionCriteria |
| Details |
1. Women not willing to give the informed consent
2. Ferritin level > 40 ug/L
3. Any other chronic illness
4. Other causes of anaemic illness like Enlarged spleen (splenomegaly), Hemolysis, Porphyria., Sickle Cell Anaemia, Thalassemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess whether alternate-day administration of iron supplement increases iron
absorption compared to consecutive-day iron administration.
|
At the end of 1st, 2nd and 3rd months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess for the safety/tolerability of the iron supplementation in both the study
groups. |
Correlate iron absorption with serum iron and iron status parameters at the end of the 1st, 2nd and 3rd months |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
01/08/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In iron-depleted women without anemia, oral iron supplements induce an increase in serum hepcidin (SHep) that persists for 24 hours, decreasing iron absorption from supplements given later on the same or next day. Consequently, iron absorption from supplements is highest if iron is given on alternate days. Whether this dosing schedule is also beneficial in women with iron-deficiency anemia (IDA) given high-dose iron supplements is uncertain. The primary objective of this study was to assess whether, in women with IDA, alternate-day administration on same dose iron increases iron absorption compared to consecutive-day iron administration. Secondary objectives were to correlate iron absorption with SHep and iron status parameters. We performing an interventional study iron absorption in women with IDA (n=60) median hemoglobin 11.5 mg/dL, who received alternate days of ferrous sulfate given at 8 AM on days 2, 4 and 6 untill day 30 labeled with stable iron isotopes 57Fe, 58Fe and 54Fe; after a third-month incorporation period,. Iron absorption on consecutive days and alternate days was assessed by measuring erythrocyte isotope incorporation. For both doses, SHep was higher on alternate days In iron-depleted women, providing iron supplements daily as divided doses increases serum hepcidin and reduces iron absorption. Providing iron supplements on alternate days and in single doses optimizes iron absorption and might be a preferable dosing regimen. These findings should be confirmed in iron-deficient anaemic patients. |