| 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
|
|
|
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
|
|
|
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. |