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

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.