Topical Delivery of Vitamin D3 as Vitamin D Supplementation

NCT ID: NCT02735200

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-12-30

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Topical Vitamin D3 application

Intervention is Application of topical Vitamin D3 Frequency: Daily Dosage: 1 gram (5000 IU) Duration: 120 days

Group Type: EXPERIMENTAL

Application of topical vitamin d3 (Top-D)

Intervention Type: DRUG

Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days

Aloe vera gel Application

Application of Aloe vera gel will be carried out Dosage: 1 gram Frequency: Daily Duration: 120 days

Group Type: ACTIVE_COMPARATOR

Application of Aloe vera gel

Intervention Type: OTHER

aloe vera gel will be applied

Dosage: 1 gram Duration: 120 days Frequency: Daily

Interventions

Application of topical vitamin d3 (Top-D)

Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days

Intervention Type: DRUG

Application of Aloe vera gel

aloe vera gel will be applied

Dosage: 1 gram Duration: 120 days Frequency: Daily

Intervention Type: OTHER

Other Intervention Names

Topical vitamin D3; TOP-D

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naif AlMasoud, MD, PhD

Role: STUDY_DIRECTOR

University of Dammam, Saudi Arabia

Locations

King Fahd Hospital of the University

Khobar, , Saudi Arabia

Countries

Saudi Arabia

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Other Identifiers

DammamU

Identifier Type: -

Identifier Source: org_study_id