A prospective, open-label, randomized, comparative clinical trial to assess the efficacy of NASO B12 or oral B12 supplementation along with standard of care in the treatment of anemia in women of reproductive age

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Background: Anemia is a prevalent health issue among women of reproductive age (WRA), often attributed to iron deficiency but also influenced by vitamin B12 deficiency. Despite widespread iron and folic acid (IFA) supplementation programs, anemia persists, necessitating comprehensive treatments. This study evaluated the efficacy of intranasal vitamin B12 supplementation (NASO B12 of Troikaa Pharmaceuticals Ltd.) with IFA compared to oral vitamin B12 with IFA and IFA alone, in WRA. Methods: This open-label, randomized clinical trial enrolled 75 anemic WRA across three centers in Lucknow, India. Participants were randomized into three groups: NASO B12 + IFA, Oral B12 + IFA, and IFA alone. In the NASO B12 and oral B12 groups, B12 supplementation was administered on alternate days for two weeks, then weekly until day 42, while IFA was given daily in all groups for 84 days. Hemoglobin (Hb) and other hematological parameters were assessed at multiple intervals. Safety evaluations included vital signs and adverse events monitoring. ANOVA was used for statistical analysis, with p<0.05 indicating significance. Results: Among 75 anemic women, NASO B12 demonstrated the fastest and most significant improvements in Hb and vitamin B12 levels, as well as a notably greater increase in RBC counts compared to both the Oral B12 and IFA groups. Hb levels increased significantly from baseline by 2.8 gm/dl at day 84. Vitamin B12 levels rose rapidly, exceeding 400 pg/mL by day 7 and sustaining through day 84. NASO B12 consistently improved RBC counts from day 7, reaching 4.53 mill/cmm by day 84. Changes in reticulocytes, ferritin, and folic acid supported hematopoietic normalization. The treatment was well-tolerated in all three groups, with no serious adverse events. Conclusions: In conclusion, NASO B12, when combined with IFA, demonstrated superior and faster efficacy in improving hematological parameters compared to oral B12 + IFA and IFA alone, making it a promising treatment option for vitamin B12 deficiency and anemia in WRA.

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