Topical vitamin D3: A randomized controlled trial (RCT).
Study Goal
The researchers aimed to test the effectiveness of a topical Vitamin D preparation (Top-D) in delivering vitamin D to patients with insufficiency or deficiency.
Results Summary
The study found that Top-D significantly increased serum 25OHD levels in the study group (37.17 ± 6.04 ng/ml) compared to the control group (10.51 ± 3.5 ng/ml), demonstrating efficacy in raising vitamin D levels via transdermal delivery.
Population
550 healthy patients with vitamin D insufficiency or deficiency, aged 18-80 years.
Effective Dosage
Top-D 1 g (containing 5000 IU of vitamin D3) applied daily.
Duration
4 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Top-D (Vitamin D3 gel made from proniosomal technology) | increase | serum 25 Hydroxy-vitamin D3 (25OHD) levels | healthy patients with vitamin D insufficiency and deficiency | from 11.03 ± 4.57 ng/l to 37.17 ± 6.04 ng/ml | raised | #1 |
Aloe vera gel | no change | serum 25 Hydroxy-vitamin D3 (25OHD) levels | healthy patients with vitamin D insufficiency and deficiency | from 10.36 ± 4.09 ng/l to 10.51 ± 3.5 ng/ml | showed no significant change | #2 |
transdermal route of vitamin D | increase | vitamin D levels | - | - | is potentially safe and can give desired results | #3 |
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.