FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/071860 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 01/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the efficacy of three drugs (Oral liposomal iron, Oral ferrous sulphate and Intravenous iron sucrose) in pregnant women between 16-28 weeks of gestation with Moderate anemia. 
Scientific Title of Study   Efficacy of Oral liposomal iron, Oral Ferrous sulphate, and Intravenous iron sucrose in antenatal women between 16-28 weeks of gestation with moderate anaemia - A Randomized controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shobika B 
Designation  Postgraduate 
Affiliation  Aarupadai Veedu Medical College and Hospital 
Address  Department Of Obstetrics and Gynaecology, A-Block, NO-22, Aarupadai Veedu Medical College and Hospital, Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  9600762111  
Fax    
Email  bshobika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepa S 
Designation  Professor and HOD of Obstetrics and Gynaecology 
Affiliation  Aarupadai Veedu Medical College and Hospital 
Address  Department Of Obstetrics and Gynaecology, A-Block, NO-22, Aarupadai Veedu Medical College and Hospital, Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  8012081902  
Fax    
Email  deepa.shanmugam@avmc.edu.in  
 
Details of Contact Person
Public Query  
Name  Shobika B 
Designation  Postgraduate 
Affiliation  Aarupadai Veedu Medical College and Hospital 
Address  Department Of Obstetrics and Gynaecology, A-Block, NO-22, Aarupadai Veedu Medical College and Hospital, Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  9600762111  
Fax    
Email  bshobika@gmail.com  
 
Source of Monetary or Material Support  
Aarupadai veedu medical college and hospital, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607402. 
 
Primary Sponsor  
Name  Aarupadai Veedu medical college and hospital 
Address  Department Of Obstetrics and Gynaecology, A-Block, NO-22, Aarupadai Veedu Medical College and Hospital, Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SHOBIKAB  Aarupadai veedu medical college and hospital  Department Of Obstetrics and Gynaecology, A-Block, NO-22, Aarupadai Veedu Medical College and Hospital, Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.
Pondicherry
PONDICHERRY 		 9600762111

bshobika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vinayaka Missions Research Foundation INSTITUTE ETHICAL COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FERROUS SULPHATE   60MG (1 - 0 - 1) per oral administration twice daily for 4 weeks 
Comparator Agent  IRON SUCROSE  200mg Intravenous administration once weekly (Based on iron requirements of each patients) 
Intervention  LIPOSOMAL IRON(Ferrous Pyrrophosphate)  30MG (1 - 0 - 1) per oral administration twice daily for 4 weeks 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1) Antenatal women between 16 to 28 weeks of gestation.
2) Antenatal women with Hemoglobin level between 7 – 9.9g% (Moderate anemia according to WHO)
3) Women with established iron deficiency anemia
4) Women with no prior history of blood transfusion
 
 
ExclusionCriteria 
Details  1) Antenatal women belong to First trimester (1-12 weeks of gestation) and more than 32 weeks of gestation
2) Women with medical complications/ Hematological disorders
3) Women with Hemoglobinopathies
4) Liver disorder like jaundice, cirrhosis, or renal failure
5) Antenatal women with Hemoglobin level less than 7g% 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase in Hemoglobin levels after taking the prescribed or administered drug to the patient over a period of 4 weeks in which we will study the Efficacy of Oral liposomal iron when compared to Oral ferrous sulphate and Intravenous iron sucrose in treatment of moderate anemia in pregnancy.   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study the patient’s compliance of oral liposomal iron in treatment of anemia in pregnancy.
2) To observe the compliance of oral ferrous sulphate in treatment of anemia in pregnancy.
3) To observe and compare the side effects of oral liposomal iron VS oral ferrous sulphate in treatment of anemia in pregnancy.
4) To observe the adverse effects of intravenous iron sucrose in treatment of anemia in pregnancy.
 		 4 weeks 
 
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   Phase 4 
Date of First Enrollment (India)   12/08/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

After getting IEC clearance from the institute and CTRI registration, informed and written consent from the patient who are willing to get enrolled in the study. Antenatal patients between 16-28 weeks of gestation attending OBG OPD will be undergone biochemical testing [Complete Hemoglobin count (CBC), Serum Ferritin, Hematocrit, Peripheral smear study] to identify the Iron deficiency anemia. Patients who are diagnosed with moderate anemia after meeting the inclusion criteria are included in the study. Patient is randomized and started allocating them in the respective study groups. One group will be started with oral liposomal iron 30mg twice daily; another group will be started with oral ferrous sulphate 60mg twice daily and the last group will be administered with 200mg Iron sucrose intravenously once weekly (Based on iron requirement). Patients will be followed up for 4 weeks for side effects. Oral compliance for both oral drugs will be collected through questionnaire. Hemoglobin levels are repeated after 4 weeks and data are collected for analysis of outcome.

 
Close