Clinical trial NCT02735200: Topical Delivery of Vitamin D3 as Vitamin D Supplementation
Official title: Topical Delivery of Vitamin D3: A Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitamin D Deficiency
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: assignment
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

all men and women with vitamin D insufficiency and deficiency Must be able to apple the topical vitamin D3 Must be willing to sign and informed consent

Exclusion Criteria:

* Those who have normal 25OHD levels

Primary outcomes:
measure: Level of Serum 25 OHD Level Pre-treatment and Post Treatment
timeFrame: baseline and 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: AlKhobar
country: Saudi Arabia
facility: King Fahd Hospital of the University
Study officials:
affiliation: University of Dammam, Saudi Arabia
name: Naif AlMasoud, MD, PhD
role: STUDY_DIRECTOR
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