Evaluation of efficacy of a nanoparticle based vitamin D formulation in correction of vitamin D levels in patients with documented deficiency or insufficiency of vitamin D
DOI:
https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20171889Keywords:
Vitamin D, Nanoparticle, 25 (OH) D, Vitamin D deficiencyAbstract
Background: In India more than 90% of apparently healthy Indians have subnormal 25(OH) D levels. To maintain sufficient vitamin D level, apart from sunlight and food containing vitamin D, supplementation with vitamin D is also required. The objective of this study was to find out effectiveness of nanoparticle based vitamin D formulations in patient of vitamin D deficiency and insufficiency
Methods: This was a prospective, open label, single arm, non-comparative, dose response post-marketing efficacy study (PMS) – phase-4 study to find the effectiveness of a nanoparticle based vitamin D formulation in adult patients between 18 to 65 years of either gender, attending/visiting the study site with documented deficiency or insufficiency of vitamin D (<30 ng/ml) or sign and symptoms of deficiency or insufficiency of vitamin D. Each subject planned to receive 60,000 IU of nanoparticle based vitamin D, once weekly, for 8 weeks orally. Serum 25(OH) D levels were measured at baseline, 4 and 8 week.
Results: The mean baseline serum 25[OH] D levels were 15.90. After treatment with nanoparticle based vitamin D there was a significant increase in the serum vitamin D levels at 4 weeks (41.03) and 8 weeks (31.38) (p<0.0001). Patients who have received treatment for at least 4 weeks’ period (n=38), the improvement (serum 25[OH] D >30 ng/ml) was seen in 84.2% patients (n=32) at the end of 4 weeks itself. There is significant increased (<0.0001) in the physical component scores of the SF-12 QOL questionnaire after 8 weeks of therapy.
Conclusions: Nanoparticle based formulation of vitamin D3 is effective and safe in correction of vitamin D levels in patients with documented deficiency or insufficiency of vitamin D. Also the safety and tolerability is well accepted and reported good to excellent by patients and physician.
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