Effect of different doses of vitamin D supplements in term of infants on EBF in south India a randomised control study

Abstract

The study was a Randomized controlled study involving two treatment groups. Healthy term newlineneonates, who were born in the study setting during the study period were randomly allocated to newlinetwo treatment groups. Group A received 400 IU and group B received 800 IU of vitamin D newlinesupplementation. Computer generated random number sequence was used for randomization. newlineAllocation concealment was done using sealed opaque envelops with random sequence in the newlinecustody of an independent statistician. The follow up of the child was done at weekly intervals newlinetill 45 days after intervention. Post treatment 25(OH) D3 levels was estimated at the end of 45 newlineday follow up period. newlineResults: newlineA total of 70 infants, with 35 infants in each group were recruited in the study. Eight children (4 newlinein each group) were lost to follow up. Both the study groups were comparable with respect to newlinevarious sociodemographic, obstetric neonatal parameters and baseline vitamin D3 level, as no newlinestatistically significant difference was observed between the two groups in any of these factors. newlineThe overall proportion of vitamin D deficiency in infants was 60% in the study population. It newlinewas 51.40% in group A and was 68.6% in group B. The proportion of vitamin D insufficiency newlinewas 35.7% in study population. In individual groups A and B, it was 42.9% and 28.6% newlinerespectively. At 45 days follow-up period 3(9.68%) cases in group A still remained in newlinedeficiency, whereas none of the children in group B had deficiency. In group A 14(45.16%) newlinechildren had insufficiency and in group B 2 (6.45%) had insufficiency. The proportion of newlinesubjects who had sufficient vitamin D levels at 45 days was 45.16% and 93.55% respectively. newlineThe mean vitamin D level at 45days was 29.54 ng/dl in group A and 42.22 ng/dl in group B with newlinea mean difference of 12.69 (95% CI 8.35 to 17.01) which was statistically significant (mean newlinedifference 12.69 ng/dl, 95% CI 8.35 to 17.01, P value lt0.001). newlineConclusions: newline1.Very high proportion of health term infants had vitamin deficiency (62.95%) and insufficiency newline(33.39%) in study population at birth. newline2. Higher dose of vitamin D supplementation (800 IU) had resulted in higher mean vitamin D newlinelevels at 45 day follow up period. newline3. The proportion of subjects who had shown improvement from vitamin D deficiency and newlineinsufficiency to vitamin D sufficiency was higher with 800 IU of vitamin D supplementation, newlinewhen compared to 400 IU of vitamin D supplementation at 45 days. newline