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CTRI Number  CTRI/2023/01/048783 [Registered on: 05/01/2023] Trial Registered Prospectively
Last Modified On: 27/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study of iron supplement in iron deficiency anemia and fatigue  
Scientific Title of Study   Investigation of efficacy and safety of different iron supplementations in nonanemic to mild anemic adults with iron deficiency and suffering from fatigue. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/22-23/008 Version: 1.00 dated 06 Nov 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyothi GS 
Designation  Consultant Gynaecologist 
Affiliation  Kala Hospital and Clinical laboratory 
Address  1105, KN Extension, 5th Cross, Triveni Road, Yeswanthpur, Near Sanjana Ice Cream, Bengaluru, Karnataka

Bangalore
KARNATAKA
560022
India 
Phone  9845257772  
Fax  -  
Email  drjyothimsrmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rumaiza Mamsa 
Designation  Medical services 
Affiliation  Meyer Organics Pvt. Ltd. 
Address  First floor, Medical service department , A 303 Road No 32 Wagle Estate Thane Mumbai

Mumbai
MAHARASHTRA
400604
India 
Phone  9167846090  
Fax  9162757002  
Email  rmamsa@meyer.co.in  
 
Details of Contact Person
Public Query  
Name  Neepa Gaba 
Designation  Scientific coordinator 
Affiliation  Meyer Organics Pvt. Ltd. 
Address  First floor, Medical service department , A 303 Road No 32 Wagle Estate Thane Mumbai

Mumbai
MAHARASHTRA
400 604
India 
Phone  912225817126  
Fax  9162757002  
Email  ngaba@meyer.co.in  
 
Source of Monetary or Material Support  
Meyer Organics Pvt Ltd A-303, Road No. 32, Wagle Estate, Thane Mumbai Maharashtra 400604 India 
 
Primary Sponsor  
Name  Meyer Organics Pvt Ltd 
Address  A-303, Road No. 32, Wagle Estate, Thane Mumbai Maharashtra 400604 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vidya Thobbi  Al-ameen Medical College  Athani Road Vijyapur, Karnataka-586108
Bijapur
KARNATAKA 		 9483100140
-
thobbividya86@gmail.com 
Dr Rekha Rajendrakumar  Chandana Hospital  4th cross, 4th main, NGEF Layout Nrupathunganagar, Nagarabhavi bengaluru- 560072
Bangalore
KARNATAKA 		 7829104881
-
dr_rajendrakumar60@yahoo.co.in 
Dr Manjit Sisode   Janseva Hospital   2nd Floor, Datta Mandir chowk, Deopur Dhule
Dhule
MAHARASHTRA 		 9850001222
-
manjit.sisode8888@gmail.com 
Dr Kalavathy HR  Kala Hospital and Clinical laboratory  1105, KN Extension, 5th Cross, Triveni Road, Yeswanthpur, Near Sanjana Ice Cream, Bengaluru, Karnataka 560022
Bangalore
KARNATAKA 		 9901748323
-
hrkalavathy@gmail.com 
Dr V G Vaidya  Lokmanya Medical Research Centre and Hospital  Forth floor OPD 401314 B Telco Road Chinchwad Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9822057766
-
vgvclinical@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Capsule Feroglobin   Dose One capsule, frequency once daily with main meal,Oral route of administration for 90 days  
Comparator Agent  Standard of care  Standard of care oral iron supplement. Type, dose one capsule and duration for 90 days will be determined by each investigator in line with the standard practices of each center.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adult male and females with the age between 18-65 years old (Both inclusive);
2.Subjects presenting with fatigue scoring between 18 to 54 based on-Fatigue Severity Scale (FSS) at screening;
3.Serum ferritin levels lower than 50 mcg/L (iron deficiency);
4.Hemoglobin levels ≥11 g/dL in non-pregnant women and men (mild anemic to non-anemic patients, defined by WHO);
5.Subjects with or without comorbidity, if comorbid, should be with stable prescription for last three months;
6.Able to give written informed consent;
7.Able to follow up through visits. 
 
ExclusionCriteria 
Details  1.Previous diagnosis of any concurrent disease or medical and/or surgical condition as a possible cause of fatigue or iron deficiency;
2.Medical history of current hematological disorders other than iron deficiency anemia (e.g. aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia, sickle cell anemia, etc.).
3.Medical history of malabsorption syndrome, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy;
4.Patients who are eligible for IV iron replacement therapy.
5.Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator
6.Any treatment with any vitamin and mineral supplements prior to inclusion to the study in the last 3 months’ period;
7.Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m raise to 2
8.Ongoing or history of malignancy within past 3 years;
9.Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 4 weeks postpartum, or have a positive serum/urine pregnancy test;
10.Known or suspected hypersensitivity to iron or any of the components of investigational products;
11.Not being competent to complete study questionnaires as per discretion of investigator. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Changes in patient response to Fatigue Severity Scale (FSS)   Screening, visit 1,visit 2, and visit 3  
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in blood hemoglobin and ferritin levels
2.Changes in quality of life (QoL) using SF-36 questionnaire at screening and visit 3.
3.Assessment of gastrointestinal adverse effects utilizing a symptoms questionnaire
4.Treatment adherence via assessment of compliance questionnaire directed to patients at visit 1, visit 2 and visit 3.  		 Screening, visit 1,visit 2, and visit 3  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   13/01/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The present research is an attempt of clinical validation of safety and effectiveness of Feroglobin capsule compared with different iron supplementations models in adult patients diagnosed with nonanemic to mild anemic iron deficiency and suffering from fatigue.

This study will provide validated evidence-based data for safety and effectiveness of various oral iron supplementation models, it will be helpful to determine most appropriate salt, formulation, dose, and duration of treatment for nonanemic to mild anemic iron deficiency and associated fatigue.

This research will help to address important medical needs to safely and effectively treat nonanemic to mild anemic iron deficiency and to reduce related fatigue. The research outcomes of this study can be instrumental for further researches in the same filed and guiding light for clinical practice.

There is need to do translational work focused at some targeted aim and come up with a treatment model for same to supply adequate iron to replenish body iron stores, improve quality of life & physiologic function, and reduce symptoms of IDA and especially fatigue. Which could be achieved through the present research. We can utilize these outcomes to develop a strategy for treating nonanemic to mild anemic iron deficiency and fatigue in adult patients in more appropriate and assured way. 

 
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