Publication:

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

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 insufficiencyMethods: 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) 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.