Short-Term Vitamin D₃ Supplementation in Children with Neurodisabilities: Comparison of Two Delivery Methods

Abstract

Background/Aims: Vitamin D deficiency is common in children with neurodisabilities. Oral vitamin D₃ may not be absorbed appropriately due to dysphagia and tube feeding. The aim of this study was to compare efficacy of vitamin D₃ buccal spray with that of oral drops. Methods: Twenty-four children with neurodisabilities (5–17 years) and vitamin D deficiency (25(OH)D ≤20 ng/mL) were randomized to receive vitamin D₃ buccal spray 800 IU/daily (n = 12) or oral drops 750 IU/daily (n = 12) for 3 months during winter. Results: Both groups had a significant increase in 25(OH)D (z = 150; p < 0.0001). The differences between baseline and final parathyroid hormone measurements did not reach significance in both groups. Markers of bone formation and resorption did not change significantly in both groups. The satisfaction with the formulation was significantly higher in the patients using spray. Conclusion: Vitamin D₃ supplementation with buccal spray and oral drops are equally effective in short-term treatment of vitamin D deficiency in children with neurodisabilities. Buccal spray may be more acceptable by the patients.

Efficacy of Vitamin D3 Buccal Spray Supplementation Compared to Other Delivery Methods: A Systematic Review of Superiority Randomized Controlled Trials

“…Satia [51] was the only one who advocated for the superiority of vitamin D3 buccal spray against the other modes of delivery in increasing plasma 25(OH)D concentrations. The remaining three RCTs [57][58][59] did not report any difference between intervention and comparator groups, and indicated the similarity and equal efficacy between different modes of vitamin D3 delivery. Table 2 summarizes the characteristics of the retrieved RCTs.…”

“…One RCT was multicenter [51] and single-blinded. The rest were single-center, two of which used open-label [57,58] and one used double-blind masking [59]. Intervention duration ranged between 30 days to 3 months and was mainly performed during winter time.…”

“…The risk of bias of the included studies is illustrated in Table 3. The Penagini [58] trial was assessed as having a high-risk of overall bias, for lacking a predefined protocol, randomization, and funding disclosure. Williams and associates [59] also conducted a trial of high overall bias, given that the predefined intervention duration was not kept.…”

“…[59] Quality assessment of the RCTs based on the Jadad [55] scale (Table 2) revealed that the Satia [51] and Todd [57] trials exhibited several bias-related issues. On the other hand, the RCT performed by Penagini [58] demonstrated the most quality issues, including bias in the randomization process, deviations from the intended interventions, overall bias and unclear risk outcomes measurement and selective reporting. In contrast, the study conducted by Williams [59] received the highest quality score among all of the studies.…”

“…In contrast, the study conducted by Williams [59] received the high score among all of the studies. Additionally, Todd [57] failed to separate the intention-to the per-protocol analyses, whereas Penagini [58] and Williams [59] lacked many of the C [60] components, including a flow diagram or details concerning dropouts and the participants at each stage. None of the RCTs reported any post-intervention adverse ev Williams et al [59] who reported small blisters on the cheek and tongue of two participan Satia [51] was the only one who advocated for the superiority of vitamin D3 buccal sp the other modes of delivery in increasing plasma 25(OH)D concentrations.…”