Topical Delivery of Vitamin D3 as Vitamin D Supplementation
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Application of topical vitamin d3 (Top-D)
Application of Aloe vera gel
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
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
Sites / Locations
- King Fahd Hospital of the University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Topical Vitamin D3 application
Aloe vera gel Application
Arm Description
Intervention is Application of topical Vitamin D3 Frequency: Daily Dosage: 1 gram (5000 IU) Duration: 120 days
Application of Aloe vera gel will be carried out Dosage: 1 gram Frequency: Daily Duration: 120 days
Outcomes
Primary Outcome Measures
Level of Serum 25 OHD Level Pre-treatment and Post Treatment
Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.
Secondary Outcome Measures
Full Information
NCT ID
NCT02735200
First Posted
March 12, 2016
Last Updated
May 11, 2017
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT02735200
Brief Title
Topical Delivery of Vitamin D3 as Vitamin D Supplementation
Official Title
Topical Delivery of Vitamin D3: A Randomized Controlled Trial (RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Vitamin D3 application
Arm Type
Experimental
Arm Description
Intervention is Application of topical Vitamin D3 Frequency: Daily Dosage: 1 gram (5000 IU) Duration: 120 days
Arm Title
Aloe vera gel Application
Arm Type
Active Comparator
Arm Description
Application of Aloe vera gel will be carried out Dosage: 1 gram Frequency: Daily Duration: 120 days
Intervention Type
Drug
Intervention Name(s)
Application of topical vitamin d3 (Top-D)
Other Intervention Name(s)
Topical vitamin D3, TOP-D
Intervention Description
Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days
Intervention Type
Other
Intervention Name(s)
Application of Aloe vera gel
Intervention Description
aloe vera gel will be applied
Dosage: 1 gram Duration: 120 days Frequency: Daily
Primary Outcome Measure Information:
Title
Level of Serum 25 OHD Level Pre-treatment and Post Treatment
Description
Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.
Time Frame
baseline and 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naif AlMasoud, MD, PhD
Organizational Affiliation
University of Dammam, Saudi Arabia
Official's Role
Study Director
Facility Information:
Facility Name
King Fahd Hospital of the University
City
AlKhobar
ZIP/Postal Code
31952
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Topical Delivery of Vitamin D3 as Vitamin D Supplementation
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