Prevalence Study of Vitamin D Deficiency and to Evaluate the Efficacy of Vitamin D3 Granules 60,000 IU Supplementation in Vitamin D Deficient Apparently Healthy Adults.

Objective: The objective of this study was to assess the prevalence of vitamin D deficiency in apparently healthy urban adults and to evaluate the efficacy of vitamin D3 granules 60,000 IU supplementation in increasing serum 25 hydroxyvitamin D [25(OH)D] levels. Material and methods: Healthy adults in an urban hospital were screened for 25(OH)D (radioimmunoassay method). Those found to be deficient or insufficient in vitamin D (defined as 25(OH)D <30 ng/ml) were supplemented with oral cholecalciferol granules 60,000 IU/week for eight weeks. Serum 25(OH)D level was estimated at the end of 60 days. Results: A total of 510 subjects (age 19-66 years) were enrolled for the study. Baseline data was available for 474 subjects and 178 subjects consumed a total of eight sachets as per the study protocol. Of these 178 subjects, 94.94% subjects were found to be vitamin D deficient (<20 ng/ml) and the mean plasma vitamin D3 25(OH)D level was 9.36 ng/ml (±5.19) at baseline. At the end of the study, the mean 25(OH)D plasma level was noted to be 29.28 ng/ml (±13.57). The mean change from baseline was 19.92 ng/ml (±13.25). Among these 178 participants only 5.06% had 25(OH)D >20 ng/ml at baseline, which increased to 78.09% at the end of the study following vitamin D3 supplementation for eight weeks. Conclusion: This study showed that vitamin D deficiency is highly prevalent in the urban healthy adult population. Eight weeks of vitamin D3 60,000 IU/week oral granules supplementation increased serum 25(OH)D to optimal levels.

A Randomized, Open Label, Multicentre Study to Evaluate the Safety and Efficacy of Cough Mixture CS1 (Pholcodeine and Promethazine - Tixylix) Versus CS2 (Noscapine, Ammonium Chloride, Sodium Citrate) in Treatment of Children with Dry Cough.

The objective of this study was to compare the efficacy and safety of cough mixture containing pholcodeine and promethazine - Tixylix (CS1) to a cough mixture which has noscapine, ammonium chloride, and sodium citrate (CS2) as its constituents in treatment of children suffering from dry cough. A total of 208 patients were enrolled at 4 sites. Of these, 179 (94 receiving CS1 and 99 receiving CS2) completed the study. Results of this study suggest that both the cough mixtures were comparable as per evaluation of their primary parameters. According to global assessment for efficacy and tolerability by parents on Day 7, Group CS1 performed better than CS2. It was also observed that no AE was reported in Group CS1 as compared to 2 AEs in Group CS2. To conclude, cough mixture combination of pholcodeine and promethazine - Tixylix exhibited efficacy and safety that was comparable with cough mixture which has noscapine, ammonium chloride, and sodium citrate. It was proven to be efficacious, safe and well tolerated in the select population.