Abstract
Purpose- To compare the change in serum 25(OH)D level 30 days after supplementation with weekly vitamin D3 doses (60,000 IU for 5 doses) in obese and overweight vs normal BMI children of 5 to 12 years age. The secondary objectives were to compare the change from baseline to day 90 post intervention in the two groups, to evaluate the correlation of the change with fat mass, and to assess the safety profile of the intervention. Method-Sixty children of 5 to 12 years age (30 overweight/obese and 30 normal BMI) with vitamin D deficiency were administered oral vitamin D3 60, 000IU weekly for 5 doses in an open labelled non randomized controlled trial. Serum 25(OH)D levels were measured before intervention and at day 7, 30 and 90 post intervention. Serum and urine calcium at each visit. Results-The change/rise in serum 25(OH)D levels was significantly less in the overweight/obese at day 7, 30 and 90. At day 30, the rise in levels was 25% lower as compared to normal BMI children. The rise from baseline to day 30 had significant negative correlation with BMI (r=-0.412, P = 0.001), fat mass (r= -0.452, P = 0.0020, fat mass index (r= -0.428, P = 0.004) and waist circumference (r=-0.388, P = 0.003). The mean circulating levels were about 20% lower in the overweight/obese at day 30 and day 90. On calculating the area under curve of the 25(OH)D profile in the two groups, there was a significant difference between the groups (3776.9 ± 780.0 in overweight/obese vs 4857.9 ± 1267.8 in normal BMI, P = 0.0002). Transient hypervitaminosis (without hypercalcemia or hypercalciuria) was seen in 2/28 of overweight/ obese and 10/30 of normal BMI group only at day 7. Conclusion—The overweight/obese children had 25% lower rise in serum 25(OH)D levels, as compared to the normal BMI children, when administered similar weekly doses of vitamin D. CTRI Number- CTRI/ REF/2020/11/038481. Date – 29 Dec 2020