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Abstract
Objective To compare the efficacy and safety of 300,000 and 600,000 IU vitamin-D single-oral dose for the treatment of vitamin-D deficiency (VDD) in young children (3 mo–3yr).
Design Double-blind randomised control trial. (Clinical Trail Registration-CTRI/2012/05/002621)
Setting Paediatric out-patient department (OPD) at a tertiary-care referral hospital.
Intervention Children (3 mo–3yr) with clinical/radiological features suggestive of VDD were screened; those found to have 25(OH)D below 15 ng/ml and meeting inclusion and exclusion criteria’s were enrolled after taking informed consent. They were randomised into two groups, one receiving 6L and other 3L vitamin-D orally stat (Stoss-therapy).
Outcome measures Primary outcome measure was proportion of children developing hypercalcaemia/and hypercalceuria at day 7–10 post-therapy. Secondary outcome measures were proportion of children with hypercalceuria at day 3–5, hypercalcaemia/and hypercalceuria at day 25–30 and 25(OH)D sufficiency at day 25–30 post-therapy.
Results Sixty children, 30 in each group were randomised to two study groups. Baseline variables were comparable in two groups. Primary outcome measure (proportion of children with hypercalcaemia/and hypercalciuria at 7–10th day) were 18.5%(5/27) in 6L and 10.7%(3/28) in 3L group [P = 00.47]. Secondary outcome measures were – i) Proportion of children with hypercalciuria (3–5th day) were 18.5%(5/27) in 6L and 7%(2/28) in 3L group (P = 0.25). ii) Proportion of children with hypercalcaemia/and hypercalciuria (25–30th day) were 18.5%(5/27) in 6L and 11%(3/28) in 3L group (P = 0.47). iii) All children in both groups had 25(OH)D levels in sufficiency range (25–30th day). With this sample size no significant difference in any of the group could be established.
Conclusions The superiority of 3L over 6L vitamin-D single-dose oral therapy for VDD in children (3 mo–3yr) in terms of safety couldn’t be established with this sample size, although the prevalence of hypercalcaemia/and hypercalciuria was observed more with 6L group. Both the regimens were effective for treating VDD at 25–30th day post-therapy.