Topical vitamin D3: A randomized controlled trial (RCT).

Objective: The intent of this study was to test the effect of Top-D, a topical Vitamin D preparation, in delivering vitamin D.

Methods: Five hundred and fifty healthy patients, with vitamin D insufficiency and deficiency were recruited after written informed consent. Demographic data was recorded, adequate history and clinical examination was done to rule out any metabolic diseases. Complete blood picture, serum calcium, phosphorous, Parathormone and 25 Hydroxy-vitamin D3 (25OHD) was carried out before enrollment of the patients. Patients were divided randomly into two groups 350 in study group and 200 in the control group. Patients in the study group were given Top-D (Vitamin D3 gel made from proniosomal technology) to apply daily on the skin. Top-D 1 g contained 5000 IU of vitamin D3. The control group was given 1 g of Aloe vera gel to be applied every day. The two groups had no knowledge to which group they belong. After 4 months serum 25OHD was tested again.

Results: Three hundred and forty five patients in study group and 192 in control group completed the study. The mean age of the patients in the both the groups was 42 years (18-80 years). The pretreatment 25OHD level in the study group was 11.03 ± 4.57 (2-12) ng/l compared to the control group 10.36 ± 4.09 (2-21) and post treatment the levels were 37.17 ± 6.04 (12-54) ng/ml and 10.51 ± 3.5 (2-19) ng/ml (p < 0.001).

Conclusion: The results of this study indicate that transdermal route of vitamin D is potentially, safe and can give desired results to raise the vitamin D levels. This route is an alternate route for supplementation of vitamin D which should be utilized.