| CTRI Number |
CTRI/2026/03/106099 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the effect of combined vitamin B12, folic acid and iron supplementation on hematological and biochemical markers in dimorphic anemia in pregnancy: A Comparative Study. |
|
Scientific Title of Study
|
Evaluation of the effect of combined vitamin B12, folic acid and iron supplementation on hematological and biochemical markers in dimorphic anemia in pregnancy- A Comparative Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-SGTCOP/2025-11-24/P10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Luthra |
| Designation |
PharmD Research Scholar |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Faculty of Pharmacy, Shree Guru Gobind Singh Tricentenary University
Budhera, Gurugram - Badli Road
Gurgaon
HARYANA
122505
India |
| Phone |
9811337339 |
| Fax |
|
| Email |
ssluthra005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Simran Luthra |
| Designation |
Research Scholar |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Faculty of Pharmacy, SGT University
Budhera, Gurugram-Badli Road
Gurgaon
HARYANA
122505
India |
| Phone |
9811337339 |
| Fax |
|
| Email |
ssluthra005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Simran Luthra |
| Designation |
Research Scholar |
| Affiliation |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Faculty of Pharmacy, SGT University
Budhera, Gurugram-Badli Road
Gurgaon
HARYANA
122505
India |
| Phone |
9811337339 |
| Fax |
|
| Email |
ssluthra005@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT College of Pharmacy, Gurugram, Haryana |
|
|
Primary Sponsor
|
| Name |
Shree Guru Gobind Singh Tricentenary University |
| Address |
Shree Guru Gobind Singh Tricentenary University, Gurugram, Haryana-122505, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Simran Luthra |
SGT Medical College, Hospital and Research Institute |
Budhera, Gurugram, Badli Road, Gurugram-122505
Gurgaon
HARYANA |
9811337339
ssluthra005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SGTCOP |
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 |
Combined vitamin B12, folic acid and iron supplementation |
Pregnant women diagnosed with dimorphic anemia will receive oral iron, folic acid and vitaminB12 supplementation once daily for a duration of 8 weeks. |
| Comparator Agent |
Iron and folic acid supplementation |
Pregnant women diagnosed with dimorphic anemia will receive oral iron and folic acid once daily for a duration of 8 weeks as per standard treatment protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Hemoglobin less than 11g per dl confirmed by laboratory investigation and peripheral smear showing dimorphic anemia.
|
|
| ExclusionCriteria |
| Details |
women with anemia due to chronic illnesses, history of hematological disorders (thalassemia, sickle cell anemia, aplastic anemia), women are already receiving vitaminB12 therapy, multiple pregnancies(twins/triplets), patients with thalassemia trait will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in hemoglobin levels & RBC indices (MCV, MCH, RDW) in pregnant women with dimorphic anemia.
Effect on serum biochemical markers: ferritin, folate and vitamin B12 level post-supplementation.
Reduction in anemia- related symptoms (fatigue, glossitis, neuropathy) |
baseline and after 8 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
23/03/2026 |
| 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="0"
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
|
This study aims to evaluate the effect of adding vitamin B12 to iron and folic acid supplementation on hematological and biochemical markers in pregnant women diagnosed with dimorphic anemia. Dimorphic anemia in pregnancy is commonly due to combined iron and vitamin deficiency. This is a prospective interventional parallel group randomized comparative study. A total of 74 pregnant women with confirmed dimorphic anemia will be enrolled and randomly divided into two groups of 37 participants each. The control group will receive iron and folic acid as per standard treatment. the intervention group will receive vitaminB12 along with iron and folic acid. Hematological parameters such as hemoglobin and red blood cell indices and biochemical parameters including serum Vitamin B12 levels will be measured at baseline and after treatment. The study will compare the improvement in these parameters between the two groups to determine the additional benefits of vitamin B12 supplementation in dimorphic anemia during pregnancy. |