DOI: http://dx.doi.org/10.18203/issn.2455-4510.IntJResOrthop20171889

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

Kishore A. Manek

Abstract


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.

 


Keywords


Vitamin D, Nanoparticle, 25 (OH) D, Vitamin D deficiency

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