Topical Delivery of Vitamin D3 as Vitamin D Supplementation
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      After obtaining the approval from the Institutional Review Board (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) I gram 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.
    

Intervention name(s): Application of topical vitamin d3 (Top-D); Application of Aloe vera gel
Intervention type(s): Drug; Other
Intervention description(s): Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days; aloe vera gel will be applied
Dosage: 1 gram Duration: 120 days Frequency: Daily
Other intervention name(s): Topical vitamin D3; TOP-D
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment