| CTRI Number |
CTRI/2025/09/094823 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of oxidative stress in anemic and non-anemic pregnant women receiving oral iron supplements in a Tertiary Care Hospital in Belagavi |
|
Scientific Title of Study
|
A comparative study of oxidative stress in anemic and non-anemic pregnant women receiving oral iron supplements in a Tertiary Care Hospital in Belagavi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansa Priyadarshini |
| Designation |
Junior Resident Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University, Belagavi |
| Address |
Room no 622, New PG Girls Hostel, JNMC campus, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
6360934989 |
| Fax |
|
| Email |
mansapriyadarshini78@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Romana Khursheed |
| Designation |
Professor, Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University, Belagavi |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9964892744 |
| Fax |
|
| Email |
romiarif@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mansa Priyadarshini |
| Designation |
Junior Resident Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University, Belagavi |
| Address |
Room no 622, New PG Girls Hostel, JNMC campus, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
6360934989 |
| Fax |
|
| Email |
mansapriyadarshini78@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Charitable Hospital, Belagavi-590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Mansa Priyadarshini |
| Address |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mansa Priyadarshini |
KLEs Dr Prabhakar Kore Charitable Hospital |
Department of Obstetrics and Gynaecology and Department of Biochemistry, Jawaharlal Nehru Medical College, Belagavi-590010 Belgaum KARNATAKA |
6360934989
mansapriyadarshini78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O280||Abnormal hematological finding onantenatal screening of mother, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anemic pregnant women taking iron supplements |
Anemic (Hb-7-10.9gm percent) pregnant women will be given oral iron which contains 60mg elemental iron twice daily |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Non-anemic pregnant women taking iron supplements |
Non-anemic pregnant women will be given oral iron which contains 60mg elemental iron once daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with singleton pregnancy with mild-moderate anemia (Hb 7-10.9gm percent)
Non-anemic Pregnant women with singleton pregnancy
Written informed consent
|
|
| ExclusionCriteria |
| Details |
Pregnant women having
1.) Pre existing chronic diseases eg Diabetes Mellitus, Chronic Hypertension, Cardiovascular diseases, Chronic Kidney Disease, Thyroid disorders, Autoimmune disorders (eg- lupus, rheumatoid arthritis)
2.) Other Hematological disorders eg- Sickle cell anemia, Thalassemia, Hemolytic anemia, Bleeding disorders
3.) Severe infections or inflammatory conditions eg- Active infections like tuberculosis, HIV, hepatitis B/C
4.) Use of medications affecting oxidative stress or iron metabolism eg – Long term corticosteroids, Antioxidant supplements (like vitamin C, E), Anti-inflammatory drugs (NSAID’s or immunosuppresants), Anti epileptic drugs, Chemotherapy drugs, Antiretroviral drugs, Antibiotics (Gentamicin, Metronidazole), Antacids, chelating agents, anticoagulants, aspirin, zinc and copper supplements
5.) Multiple pregnancy
6.) Iron overload disorders (eg- hemochromatosis)
7.) Smoking, Alcohol, Drug abuse
8.) Severe malnutrition or dietary restrictions (BMI smaller than 18.5kg/m2-underweight)
9.) Obese (BMI greater than 30kg/m2)
10.) Refusal to give consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxidative stress in anemic and nonanemic pregnant women due to iron supplementation |
At 14-20wks (Before starting iron supplementation) and
3-6 wks after starting iron supplementation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
26/09/2025 |
| 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="1" Months="0" 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
|
Need for the study- Pregnancy is a state of negative iron balance. Iron is required for increased demand of pregnancy which includes fetal growth and hematopoietic requirements in mother. Iron deficiency anemia is the most common nutritional deficiency among pregnant women. To combat the negative iron balance of pregnancy, prophylactic iron therapy is prescribed to the non-anemic pregnant women in routine practice. But the safety of uniform iron supplementation across all pregnant women is controversial. It has been observed in previous research that iron supplementation may cause oxidative stress in pregnancy. Both iron overload and iron deficiency could promote the generation of free radicals and result in cellular damage. In pregnancy, iron supplementation has been observed to heighten the oxidative stress as evidenced by increased levels of Malondialdehyde (MDA) in the serum of mothers and the placenta. Prenatal iron supersaturation has also been associated with an elevated risk of miscarriage, prematurity, low birth weight, and being small for gestational age with oxidative stress identified as one of the potential underlying mechanism. High levels of haemoglobin, hematocrit, and ferritin are found to be associated with increased risk of fetal growth restriction, gestational diabetes mellitus, pre eclampsia, preterm labour. In pregnant women without iron deficiency anemia, prophylactic iron supplementation has been shown to induce oxidative stress and compromise the overall antioxidant capacity of the body. This has not been explored adequately in the recent times. Hence this study will be carried out with the objective of comparing oxidative stress among anemic and non-anemic antenatal women receiving oral iron supplements. Methodology: Singleton pregnant women between 14-20weeks of gestation will be recruited from the outpatient department after written informed consent. They will be recruited under 2 groups anemic (Hb-7 to 10.9gm percent ) and non anemic (Hb greater than 11gm percent) .Non anemic women will be given oral iron which contains 60mg elemental iron once daily and anemic women will be given oral iron which contains 60mg elemental iron twice daily. They will also be given folic acid 5mg and calcium supplements. 5ml of blood will be collected from the study subjects out of which 2 ml will be transferred to EDTA tube to analyze hemoglobin, hematocrit and other red cell indices by fully automated cell counter analyzer and 3 ml to plain yellow capped tube to analyze biochemical parameters like Serum Ferritin by fully autoanalyzer (kit method). Levels of MDA by spectrophotometric method using TBRAS kit and Total Antioxidant Capacity (TAC) by ELISA will be measured at the start of study and 3-6 weeks later respectively. The study subjects will be enquired about the compliance and side effects of supplemented drugs, during their follow up visits. |