| CTRI Number |
CTRI/2025/09/094880 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Do vitamin B12 tablets work as well as vitamin B12 injections for pregnant women with mild to moderate vitamin B12 deficiency? |
|
Scientific Title of Study
|
Comparison of effect of oral versus intramuscular vitamin b12 administration on its serum levels 3 months post treatment among pregnant women with mild and moderate vitamin b12 deficiency in second trimester - a Randomized controlled trial |
| Trial Acronym |
B12 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deboleena Sinha |
| Designation |
Junior Resident, Department of Obstetrics and gynaecology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynecology, Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9131367451 |
| Fax |
|
| Email |
deboleena.sinha.7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashwini Vishalakshi.L |
| Designation |
Assistant Professor, Department of Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynecology, Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9600203086 |
| Fax |
|
| Email |
akshivishal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ashwini Vishalakshi.L |
| Designation |
Assistant Professor, Department of Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynecology, Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9600203086 |
| Fax |
|
| Email |
akshivishal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural research fund committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Intramural research fund committee JIPMER |
| Address |
IEC office, Second floor, Admin Block, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India, 605006 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Deboleena Sinha |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
Antenatal Ward and Antenatal Out Patient Department, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Pondicherry
PONDICHERRY |
9131367451
deboleena.sinha.7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E538||Deficiency of other specified B group vitamins, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Vitamin B12 |
1000mcg IM daily for 7 days - weekly for 6 weeks - monthly for 3months total |
| Intervention |
T. Vitamin b12 (cyanocobalamin) |
1000mcg PO daily for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women 18 years and above between 14-28 weeks diagnosed with Vitamin B12 deficiency (Serum Vitamin B12 levels less than 200pg/ml) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of oral versus intramuscular vitamin b12 administration on its mean serum levels 3 months post treatment among pregnant women with mild to moderate Vitamin B12 deficiency in second trimester of pregnancy |
Comparison of serum Vitamin B12 between the two groups of intervention at 3 months post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the changes in hematological parameters(hemoglobin, MCV, MCH, MCHC, peripheral smear, platelet count, total leukocyte counts) 3 months post treatment between the groups
To compare the adverse effects between the two groups |
Comparison of hematological parameters between the two groups of intervention at basline, 1 month, 2 month & 3 month post initiation of treatment |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
01/10/2025 |
| 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 Yet Recruiting |
| 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 will be conducted in the Department of Obstetrics and Gynaecology, WCH, JIPMER, Puducherry, among pregnant women attending the antenatal outpatient department of admitted to antenatal wards. Women will be enrolled if they meet the inclusion criteria, which includes being aged 18 years or older, having a gestational age between 14-28 weeks and diagnosed with Vitamin B12 deficiency, defined as serum Vitamin B12 levels below 200pg/ml. Those with a history of Impaired intestinal absorption ( gastrectomy, ileal resection, crohn’s disease, radiation induced gastritis), severe neurological symptoms, severe anemia(hb less than 7g/dL), thrombocytopenia (less than 75,000), renal disease, co existing folate deficiency will be excluded. Written informed consent will be obtained in both English and the local language. A detailed medical history, including dietary intake, will be recorded in a standardized proforma along with a dietary questionnaire. Baseline investigations including CBC, peripheral smear, will be conducted. Clinical signs and symptoms of vitamin b12 deficiency will also be documented. Participants will then be randomly assigned in a 1:1 ratio to one of the two treatment groups using a computerised random number generator. An independent person will allocate the sequence. Allocation will be concealed using sequentially numbered opaque sealed envelopes (SNOSE) containing the drug codes. Each women will be administered the drug in the envelope assigned corresponding to her allocation code. Group A will receive 1000micrograms oral cyanocobalamin once daily for 90 days, while group B will recieve intramuscular cyanocobalamin at 1000 microgram daily for 7 days, followed by weekly injections for 6 months, during which CBC, peripheral smear, RBC indices, clinical symptom improvement will be assessed and at the end of 3 months serum vitamin b12 levels will be reassessed . At the end of the study period, data will be analysed for primary outcomes, including serum vitamin b12 normalisation and secondary outcomes such as hematological improvement, resolution of clinical symptoms and treatment adherence. Ethical approval for the study will be obtained from the Institutional Ethics Committee and all the participants will be observed in hospital until discharge. |