Topical Delivery of Vitamin D3 as Vitamin D Supplementation
Status:
Completed
Trial end date:
2016-12-30
Target enrollment:
Participant gender:
Summary
After obtaining the approval from the IRB of University of Dammam and informed consent from
550 healthy patients, with vitamin D deficiency and vitamin D insufficiency and deficiency
were recruited. Age, weight and height will be taken, a detailed history, meticulous clinical
examination was performed to rule out any diseases and complete blood picture, serum calcium,
phosphorous, alkaline phosphatase, Parathormone and 25 Hydroxy-vitamin D (25OHD) will be
done. 25-Hydroxy Vitamin D3 was measured in house by chemiluminescence immunoassay (CLIA) and
≥30ng/mL was taken as normal, 21-29ng/mL as insufficiency and ≤20 ng/mL as deficiency. The
participants were divided into two groups of 350 in study arm and 200 in control arm. All
participants were instructed not to change their dietary habits and life style till the study
was over. The study group of women were instructed to apply to apply Top-D (Proniosomal
Delivered- Vitamin D3) 1 gram containing 5000 IU of vitamin D3. The second group used 1 gram
of Aloe vera gel. The participants had no knowledge to which group they belong. A second
blood sample was taken at the end of 4 months and the data was entered in the data base and
analyzed using SPSS Inc version 19.
Phase:
Phase 2
Details
Lead Sponsor:
Dammam University
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins