| CTRI Number |
CTRI/2024/07/070773 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study of Iron supplement in anemic pregnant women |
|
Scientific Title of Study
|
An open-label, randomized, comparative study investigating efficacy and safety of iron supplement vs. ferrous ascorbate tablet in pregnant women with iron deficiency anemia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/003 Version: 1.00 dated 24 April 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ameet Patki |
| Designation |
Senior Consultant |
| Affiliation |
Fertility Associates Clinic |
| Address |
81, Fourth Floor, Gupte House, Police Station, Swami Vivekananda Rd, near Khar, Khar, Ram Krishna Nagar, Khar West,
Mumbai
MAHARASHTRA
400054
India |
| Phone |
9820132585 |
| Fax |
- |
| Email |
ameetpatki@fertilityassociates.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Shah |
| Designation |
Director and Chief Scientific Officer |
| Affiliation |
Generex Pharmassist Pvt. Ltd |
| Address |
Fourth Floor 4B, 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 4B, 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidya Thobbi |
Al-Ameen Medical College |
Athani Road, Vijyapur
Bijapur
KARNATAKA |
9483100140
-
thobbividya86@gmail.com |
| Dr Ameet Patki |
Fertility Associates Clinic |
81, 4th Floor, Gupte House, Police Station, Swami Vivekananda Rd, near Khar, Khar, Ram Krishna Nagar, Khar West,
Mumbai
MAHARASHTRA |
9820132585
-
ameetpatki@fertilityassociates.in |
| Dr Jyothi GS |
Kala Hospital and Clinical laboratory |
1105, KN Extension,
5th Cross, Triveni
Road, Yeswanthpur
Bangalore
KARNATAKA |
9845257772
-
drjyothimsrmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
| 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 |
Ferrous ascorbate tablet (Marketed) |
Once daily after lunch for 12 weeks (1 tablet of 100 mg). |
| Intervention |
Iron supplement (SunActiveTM Fe tablet containing emulsified microsomal® ferric pyrophosphate) |
Once daily before lunch for 12 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 |
1. Changes in hemoglobin levels at screening week 4, week 8 and end of the study.
2. Adverse events profile from baseline to end of the study.
|
Screening, baseline, week 4, week 8 and end of the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in ferritin levels at screening, week 4, week 8 and end of the study.
2.Changes in fatigue severity score at screening, week 4, week 8 and end of the study.
3.Changes in serum iron at screening and end of the study.
4.Changes in reticular haemoglobin (Hb) at screening and end of the study.
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, week 4, week 8 and end of the study.
|
Screening, baseline, week 4, week 8 and end of the study. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| Date of Study Completion (India) |
16/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
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
|
The rationale for this
study lies in the need to address IDA in pregnant women with a focus on
efficacy and safety. Iron pyrophosphate, recognized as “generally recognized as
safe (GRAS)†by United States Food and Drugs Administration (USFDA) Code of
Federal Regulation. and European Food Safety Authority (EFSA), presents
promising advantages over conventional oral iron salts, including higher
bioavailability and reduced gastrointestinal side effects.
This investigation seeks to assess the efficacy and safety of iron
supplement SunActiveTM Fe tablet containing EMFP in managing IDA
during the second trimester of singleton pregnancies. By comparing the effects
of a 27 mg SunActiveTM Fe tablet containing EMFP formulation with a
widely used ferrous ascorbate tablet, the study aims to establish the comparative
efficacy of SunActiveTM Fe tablet. Such a comparison allows for a
robust evaluation of whether SunActiveTM Fe tablets offer superior
outcomes in terms of improving hemoglobin levels and alleviating IDA symptoms,
thereby enhancing clinical relevance.
Additionally, the comparative nature of the study enables a
comprehensive evaluation of the safety profile of SunActiveTM Fe
tablets. By comparing adverse events and side effects between the
investigational and standard treatments, the study can provide insights into
the overall safety profile of SunActiveTM Fe tablet, which is
crucial for informed decision-making by healthcare providers.
In essence, conducting a comparative study against a standard
marketed drug provides a comprehensive assessment of the efficacy, safety, and
clinical utility of the investigational treatment, thereby guiding clinical
practice and improving patient care.
|