| CTRI Number |
CTRI/2024/06/069166 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Iron supplement in anemic pregnant women. |
|
Scientific Title of Study
|
An open-label, randomized, parallel arm, comparative clinical study to evaluate efficacy of iron supplement formulations in pregnant women affected by iron deficiency
anemia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/001 Version: 1.00 dated 22nd April 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyothi GS |
| Designation |
Principal Investigator |
| Affiliation |
Kala Hospital and Clinical laboratory |
| Address |
No. 1105, KN Extension, fifth Cross road, Triveni Road, Yeswanthpur
Bangalore
KARNATAKA
560022
India |
| Phone |
9845257772 |
| Fax |
- |
| Email |
drjyothimsrmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Shah |
| Designation |
Director and Chief Scientific Officer |
| Affiliation |
Generex Pharmassist Pvt. Ltd. |
| Address |
Fourth Floor Four B, DGP House, 88-C, Old Prabhadevi Road, Prabhadevi
Mumbai
MAHARASHTRA
400025
India |
| Phone |
9867385041 |
| Fax |
- |
| Email |
alok@jbkhokhani.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Srivastav |
| Designation |
Manager - Science and Technical Marketing |
| Affiliation |
Generex Pharmassist Pvt. Ltd. |
| Address |
Fourth Floor Four B, DGP House, 88-C, Old Prabhadevi Road, Prabhadevi
Mumbai
MAHARASHTRA
400025
India |
| Phone |
9136554279 |
| Fax |
- |
| Email |
technical@generex.in |
|
|
Source of Monetary or Material Support
|
| Generex Pharmassist Pvt. Ltd., 4
th Floor 4B, DGP House, 88-C, Old
Prabhadevi Road, Prabhadevi, Mumbai,
Maharashtra- 400025. |
|
|
Primary Sponsor
|
| Name |
Generex Pharmassist Pvt. Ltd. |
| Address |
4th Floor 4B, DGP House, 88-C, Old
Prabhadevi Road, Prabhadevi, Mumbai,
Maharashtra- 400025. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidya Thobbi |
Al-Ameen Medical College |
Department of Obstetrics and Gynaecology, Vijayapur
586101
Bijapur
KARNATAKA |
9483100140
-
thobbividya86@gmail.com |
| Dr Jyothi GS |
Kala Hospital and Clinical laboratory |
No. 1105, KN Extension, fifth Cross road, Triveni Road, Yeswanthpur
Bangalore
KARNATAKA |
9845257772
-
drjyothimsrmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iron supplement (emulsified microsomalTM ferric pyrophosphate
i.e. EMFP) capsule |
once daily before lunch for 04 weeks (1 capsule of 27
mg) |
| Intervention |
Iron supplement (emulsified microsomalTM ferric pyrophosphate
i.e. EMFP) tablet |
once daily before lunch for 04 weeks (1 tablet of 27 mg) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Participants meeting all of the following criteria will be eligible for the study: 1. Pregnant females with the age between 20-35 years (both inclusive); 2. Presence of a live, singleton, intrauterine fetus and dating ultrasound at screening that indicates a pregnancy that would be between the week 13 to week 16 (both inclusive); 3. Female with primi or multigravida; 4. Pregnant females without any other comorbidity; 5. Hemoglobin levels between 9-10.5 g/dl (both inclusive); 6. With or without fatigue associated with anemia; 7. Serum ferritin levels below 15 mcg/L; 8. Able to give written informed consent; 9. Able to follow up through visits. |
|
| ExclusionCriteria |
| Details |
Participants meeting any of the following criteria will not be eligible for the study: 1. Pregnant women of less than 13 weeks and more than 16 weeks of gestation; 2. Pregnant female with complicated pregnancy history or ongoing treatment for the same; 3. Pregnant women with complications like bleeding piles, excessive emesis, active peptic ulcer, diabetes, hypertension, eclampsia,
hypothyroidism, hyperthyroidism and multiple pregnancy; 4. Fetal anomaly if detectable when an initial ultrasound is done to date
the pregnancy; 5. Participants on any concomitant therapy for treating IDA during study period; 6. Not willing to provide consent or follow up; 7. Any condition from investigator viewpoint can affect participant participation in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in hemoglobin levels
|
at screening and end of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in ferritin levels.
2. Changes in fatigue severity score.
3. Changes in serum iron.
4. Changes in reticular haemoglobin (Hb).
5. Changes in score of symptoms related to iron deficiency as well as
gastrointestinal events after iron supplementation such as
breathlessness, palpitations, headaches, dizziness, irritability and
constipation, abdominal discomfort, nausea and heartburn on 4-point
ordinal scale. (0- none, 1- mild, 2- moderate, 3- severe) |
at screening,
baseline, and end of the study. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This study aims to address the pressing issue of IDA in pregnant women by focusing on efficacy. Iron pyrophosphate, recognized as "generally recognized as safe (GRAS)" by the United States Food and Drug Administration (USFDA) Code of Federal Regulation and the European Food Safety Authority (EFSA), holds promise due to its advantages over conventional oral iron salts, including increased bioavailability and reduced gastrointestinal side effects. The choice of iron supplement formulation is critical as it can significantly impact treatment efficacy, tolerability, and patient adherence. While various formulations, such as tablets and capsules, are available for clinical use, there’s a notable lack of comprehensive comparative data, especially concerning pregnant women with IDA. This investigation seeks to fill this gap by assessing the efficacy of EMFP tablets specifically during the second trimester of singleton pregnancies. By comparing the effects of a 30 mg EMFP tablet formulation with a capsule formulation, the study aims to establish a clear understanding of their relative efficacy. Such a comparison allows for a robust evaluation of which EMFP formulation offers superior efficacy in improving hemoglobin levels and alleviating IDA symptoms, thereby enhancing clinical relevance. Furthermore, by examining adverse events associated with both formulations, the study can provide insights into the overall safety profile of EMFP tablets, essential for informed decision-making by healthcare providers. Additionally, exploring patient preferences and adherence to each formulation could offer valuable insights into their clinical utility and acceptability. Conducting a comparative study provides a comprehensive assessment of the efficacy, safety, and practicality of the investigational treatment, thereby guiding clinical practice and ultimately improving patient care |