Topical Delivery of Vitamin D3 as Vitamin D Supplementation

NCT02735200 | Completed Phase 2 Results DMC

• 1 other identifier: DammamU
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 5 months

Study Arms (2)

Topical Vitamin D3 application

EXPERIMENTAL

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

Drug: Application of topical vitamin d3 (Top-D)

Aloe vera gel Application

ACTIVE COMPARATOR

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

Other: Application of Aloe vera gel

Interventions

Application of topical vitamin d3 (Top-D) DRUG

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

Also known as: Topical vitamin D3, TOP-D

Topical Vitamin D3 application

Application of Aloe vera gel OTHER

aloe vera gel will be applied Dosage: 1 gram Duration: 120 days Frequency: Daily

Aloe vera gel Application

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those who have normal 25OHD levels

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

King Fahd Hospital of the University

Khobar, 31952, Saudi Arabia

Location

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  PMID: 24711745 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

we did have a limitation of not performing the absorption studies, which could have strenthened the study robustly.

Results Point of Contact

• Title: Dr Dalal Bubshait
• Organization: Dammam University

dbubshait@ud.edu.sa

+966505848281

Study Officials

• Naif AlMasoud, MD, PhD

  University of Dammam, Saudi Arabia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: assignment

Study Record Dates

• First Submitted: March 12, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 30, 2016
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)