SAFETY AND EFFECTIVENESS OF COMBINED CALCIUM, VITAMIN D3, AND BVITAMIN SUPPLEMENTATION IN INDIAN PREGNANT WOMEN: RETROSPECTIVE REAL WORLD INDIAN STUDY

Objective: Micronutrient deficiencies during pregnancy are associated with adverse maternal and fetal outcomes. This study evaluates the effectiveness and safety of combined supplementation with calcium carbonate, vitamin D3, methylcobalamin, L-methyl folate calcium, and pyridoxal-5-phosphate in pregnant women. Methods: A multicentric, retrospective, observational study was conducted across 273 healthcare facilities in India over an 18-month period (March 2023 to August 2024), enrolling pregnant females who received the combined supplementation. Demographic characteristics, medical history, supplementation regimen, pregnancy outcomes, and maternal and fetal health indicators were extracted from existing medical records. The statistical analyses were conducted employing SPSS software. Results: A total of 2,799 pregnant women with a mean maternal age of 28.8 years were included in the study. The majority of the females had full-term deliveries (89.92%). Preterm births occurred in 10.08% of pregnant women, while gestational hypertension, diabetes, and Intrauterine Growth Restriction (IUGR) were seen in 13.47%, 11.36%, and 9.75% of cases, respectively. Mean maternal blood pressure was 123.7 ±10.6 / 85.7 ±16.1 mmHg. Hemoglobin levels averaged 10.0 g/dL ±4.0, and 79.35% of participants had negative urinary protein tests. Neonatal mean birth weight and average age at gestation were 2425.6 g ±567.4 and 32.2 ±11.1weeks, respectively. The mean APGAR scores at one and five minutes averaged 7.2 ±1.7. No adverse events were reported. Conclusion: The combined supplementation was found to be effective and well-tolerated, supporting favorable maternal and fetal outcomes during pregnancy