Comparison of 300,000 and 600,000 IU Oral Vitamin-D Bolus for Vitamin-D Deficiency in Young Children.
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 - 3 y).


METHODS
This double-blind randomized control trial (Clinical Trail Registration-CTRI/2012/05/002621) was conducted in the Pediatric out-patient department (OPD) at a tertiary-care referral hospital. Children (3 mo - 3 y) with clinical/radiological features suggestive of VDD were screened; those found to be having 25(OH)D below 15 ng/ml and meeting inclusion and exclusion criteria's were enrolled after taking informed consent. They were randomized into two groups, one receiving 600,000 and other 300,000 IU vitamin-D orally stat (Stoss-therapy). Primary outcome measure was proportion of children developing hypercalcemia/and hypercalciuria at day 7-10 post-therapy. Secondary outcome measures were proportion of children with hypercalciuria at day 3-5, hypercalcemia/and hypercalciuria at day 25-30 and 25(OH)D sufficiency at day 25-30 post-therapy.


RESULTS
Sixty children, 30 in each group were randomized to two study groups. Baseline variables were comparable in two groups. Primary outcome measure (proportion of children with hypercalcemia/and hypercalciuria at 7 - 10th d) were 18.5 % (5/27) in 600,000 and 10.7 % (3/28) in 300,000 IU group (P = 0.47). Secondary outcome measures were - i) Proportion of children with hypercalciuria (3-5th d) were 18.5 % (5/27) in 600,000 and 7 % (2/28) in 300,000 group (P = 0.25). ii) Proportion of children with hypercalcemia/and hypercalciuria (25-30th d) were 18.5 % (5/27) in 600,000 and 11 % (3/28) in 300,000 group (P = 0.47). iii) All children in both groups had 25(OH)D levels in sufficiency range (25-30th d). With this sample size no significant difference in any of the group could be established.


CONCLUSIONS
The superiority of 300,000 over 600,000 IU vitamin-D single-dose oral therapy for VDD in children (3 mo - 3 y) in terms of safety could not be established with this sample size, although the prevalence of hypercalcemia/and hypercalciuria was observed more with 600,000 IU group. Both the regimens were effective for treating VDD at 25-30th d post-therapy.
Department of Pediatrics, Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.
Jiyalal
J
Harnot
Department of Pediatrics, Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India. sanjay06verma@yahoo.com.
Sanjay
S
Verma
Department of Pediatrics, Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.
Sunit
S
Singhi
Department of Pediatrics, Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.
Naveen
N
Sankhyan
Department of Endocrinology, Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Naresh
N
Sachdeva
Department of Pediatrics, Advanced Pediatric Center, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012, India.
Bhavneet
B
Bharti
D000284:Administration, Oral; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007194:India; D007223:Infant; D008297:Male; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage*; D014808:Vitamin D Deficiency / Q000188:drug therapy*
D014807:Vitamin D
Cholecalciferol; Metabolic bone disease; Rickets; Stoss therapy
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