300,000 IU or 600,000 IU of Oral Vitamin D3 for Treatment of Nutritional Rickets: A Randomized Controlled Trial.
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Date
2014-04
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Abstract
Objective: To evaluate the non-inferiority of a lower therapeutic
dose (300,000 IU) in comparison to standard dose (600,000) IU of
Vitamin D for increasing serum 25(OH) D levels and achieving
radiological recovery in nutritional rickets.
Design: Randomized, open-labeled, controlled trial.
Setting: Tertiary care hospital.
Participants: 76 children (median age 12 mo) with clinical and
radiologically confirmed rickets.
Intervention: Oral vitamin D3 as 300,000 IU (Group 1; n=38) or
600,000 IU (Group 2; n=38) in a single day.
Outcome variables: Primary: Serum 25(OH)D, 12 weeks after
administration of vitamin D3; Secondary: Radiological healing
and serum parathormone at 12 weeks; and clinical and
biochemical adverse effects.
Results: Serum 25(OH)D levels [geometric mean (95% CI)]
increased significantly from baseline to 12 weeks after therapy in
both the groups [Group 1: 7.58 (5.50–10.44) to 16.06 (12.71–
20.29) ng/mL, P<0.001]; Group 2: 6.57 (4.66–9.25) to 17.60
(13.71–22.60, P<0.001]. The adjusted ratio of geometric mean
serum 25(OH)D levels at 12 weeks between the groups (taking
baseline value as co-variate) was 0.91 (95% CI: 0.65–1.29).
Radiological healing occurred in all children by 12 weeks. Both
groups demonstrated significant (P<0.05) and comparable fall in
the serum parathormone and alkaline phosphatase levels at 12
weeks. Relative change [ratio of geometric mean (95% CI)] in
serum PTH and alkaline phosphatase, 12 weeks after therapy,
were 0.98 (0.7–1.47) and 0.92 (0.72–1.19), respectively. The
serum 25(OH)D levels were deficient (<20 ng/mL) in 63% (38/60)
children after 12 weeks of intervention [Group 1: 20/32 (62.5%);
Group 2: 18/28 (64.3%)]. No major clinical adverse effects were
noticed in any of the children. Hypercalcemia was documented in
2 children at 4 weeks (1 in each Group) and 3 children at 12 weeks
(1 in Group 1 and 2 in Group 2). None of the participants had
hypercalciuria or hypervitaminosis D.
Conclusion: A dose of 300,000 IU of vitamin D3 is comparable to
600,000 IU, administered orally, over a single day, for treating
rickets in under-five children although there is an unacceptably
high risk of hypercalcemia in both groups. None of the regime is
effective in normalization of vitamin D status in majority of
patients, 3 months after administering the therapeutic dose.
Description
Keywords
Children, Rickets, Treatment, Serum 25(OH)D, Stoss Therapy, Vitamin D3
Citation
Mittal Hema, Rai Sunita, Shah Dheeraj, Madhu S V, Mehrotra Gopesh, Malhotra Rajeev Kumar, Gupta Piyush. 300,000 IU or 600,000 IU of Oral Vitamin D3 for Treatment of Nutritional Rickets: A Randomized Controlled Trial. Indian Pediatrics. 2014 Apr; 51(4): 265-272.