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CTRI Number  CTRI/2025/02/081056 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Drawing blood Not giving anything to the patient]  
Study Design  Other 
Public Title of Study   Vitamin B12 deficiency associated oxidative stress during pregnancy 
Scientific Title of Study   Maternal Vitamin B12 status during pregnancy:Association of low vitamin B12 with markers of oxidative stress- MPO,Ox-LDL and IsoPs 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anita Motiani 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  Department of Biochemistry, Academic Block, AIIMS Rajkot

Rajkot
GUJARAT
360006
India 
Phone  9045802978  
Fax    
Email  motiani.anita23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anita Motiani 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  Department of Biochemistry, Academic Block, AIIMS Rajkot

Rajkot
GUJARAT
360006
India 
Phone  9045802978  
Fax    
Email  motiani.anita23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anita Motiani 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Rajkot 
Address  Department of Biochemistry, Academic Block, AIIMS Rajkot

Rajkot
GUJARAT
360006
India 
Phone  9045802978  
Fax    
Email  motiani.anita23@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Rajkot, Khanderi, Para Pipaliya, Rajkot Pin Code 360006 Gujarat 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rajkot 
Address  AIIMS Rajkot, Gujarat 
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 Anita Motiani  All India Institute of Medical Sciences Rajkot  Biochemistry Department, Clinical Laboratory Complex, Ground Floor, IPD building
Rajkot
GUJARAT 
9045802978

motiani.anita23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee AIIMS Rajkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O251||Malnutrition in pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ferritin Vitamin B12   Anemia due to Vitamin B12 deficiency will be compared with anemia due to ferritin deficiency in the blood samples of patients collected over a period of 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant patients having Vitamin B12 deficiency anemia not taking Vitamin B12 supplements with Hb levels less than 11 gm/dl 
 
ExclusionCriteria 
Details  Chronic illness like diabetes mellitus, hypertension, cancer, iron deficiency anemia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Vitamin B12 deficiency anemia in pregnant females causes oxidative stress and poses risk to both mother and the foetus  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Fetal growth retardation & premature or preterm delivery  at the time of delivery 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
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)   01/03/2025 
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="2"
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  

A.    Background- Nutritional deficiencies among pregnant women is a public health problem of global concern. It is the most frequently encountered problem in pregnant women in India, & is a major cause of maternal and fetal complications including mortality. Vitamin B12 deficiency is an important contributor to deficiency manifestations, in addition to iron and folate deficiency. In India, anemia during pregnancy is a significant public health problem, with 45.7% of pregnant women in urban areas and 52.1% in rural areas having hemoglobin levels <11 g/dl.

B.    Objectives- a) To measure levels of oxidative stress markers – MPO, Ox-LDL & IsoPs in pregnant females having a vitamin B12 deficiency b) To detect vitamin B12-mediated oxidative damage in the mothers.

C.     Methodology- It is a hospital-based cross-sectional study. The study will be carried out in the Clinical Biochemistry lab in collaboration with the Department of Obstetrics & Gynecology & Department of Pathology at AIIMS, Rajkot. The pregnant females coming for their antenatal visits will be selected from the outpatient department of Obstetrics & Gynecology. Patients showing signs & symptoms of anemia will be the main target group of this study. Diagnosis of anemia will be made using the following WHO criteria: hemoglobin levels less than 11.0 g/dl in the first and third trimesters and less than 10.5 g/dl in the second trimester with the presence of signs and symptoms. The patients having Vitamin B12 deficiency (Vit B12 levels - 1st trimester 118 - 438 pg/ml, 2nd trimester 130 - 656 pg/ml, 3rd trimester 99 - 526 pg/ml) will be differentiated from patients having Iron deficiency (Ferritin levels <10 Microgm/L). Inclusion criteria: All pregnant females (age group 18 – 40 years) with Vitamin B12 deficiency, irrespective of their gestational age. All subjects will be undergoing interviews using questionnaires. The sample size will be of 385.    

 
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