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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
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
March 12, 2016
Last Updated
May 11, 2017
Sponsor
Imam Abdulrahman Bin Faisal University
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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
Citations:
PubMed Identifier
9082230
Citation
Riccio PA, Zingaretti C, Milani M, Ricci Petitoni G, Monti G, Pavanello PM. [Thymoma: diagnosis and surgical treatment]. Minerva Chir. 1996 Sep;51(9):663-7. Italian.
Results Reference
background
PubMed Identifier
19700896
Citation
Sadat-Ali M, AlElq A, Al-Turki H, Al-Mulhim F, Al-Ali A. Vitamin D levels in healthy men in eastern Saudi Arabia. Ann Saudi Med. 2009 Sep-Oct;29(5):378-82. doi: 10.4103/0256-4947.55168.
Results Reference
background
PubMed Identifier
20213587
Citation
Elsammak MY, Al-Wosaibi AA, Al-Howeish A, Alsaeed J. Vitamin d deficiency in Saudi Arabs. Horm Metab Res. 2010 May;42(5):364-8. doi: 10.1055/s-0030-1248296. Epub 2010 Mar 8.
Results Reference
background
PubMed Identifier
22870413
Citation
Al-Elq AH. The status of Vitamin D in medical students in the preclerkship years of a Saudi medical school. J Family Community Med. 2012 May;19(2):100-4. doi: 10.4103/2230-8229.98293.
Results Reference
background
PubMed Identifier
15885294
Citation
Grant AM, Avenell A, Campbell MK, McDonald AM, MacLennan GS, McPherson GC, Anderson FH, Cooper C, Francis RM, Donaldson C, Gillespie WJ, Robinson CM, Torgerson DJ, Wallace WA; RECORD Trial Group. Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial. Lancet. 2005 May 7-13;365(9471):1621-8. doi: 10.1016/S0140-6736(05)63013-9.
Results Reference
background
PubMed Identifier
15860827
Citation
Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, Baverstock M, Birks Y, Dumville J, Francis R, Iglesias C, Puffer S, Sutcliffe A, Watt I, Torgerson DJ. Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. BMJ. 2005 Apr 30;330(7498):1003. doi: 10.1136/bmj.330.7498.1003.
Results Reference
background
PubMed Identifier
16481635
Citation
Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE, Bassford T, Beresford SA, Black HR, Blanchette P, Bonds DE, Brunner RL, Brzyski RG, Caan B, Cauley JA, Chlebowski RT, Cummings SR, Granek I, Hays J, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Johnson KC, Judd H, Kotchen JM, Kuller LH, Langer RD, Lasser NL, Limacher MC, Ludlam S, Manson JE, Margolis KL, McGowan J, Ockene JK, O'Sullivan MJ, Phillips L, Prentice RL, Sarto GE, Stefanick ML, Van Horn L, Wactawski-Wende J, Whitlock E, Anderson GL, Assaf AR, Barad D; Women's Health Initiative Investigators. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med. 2006 Feb 16;354(7):669-83. doi: 10.1056/NEJMoa055218. Erratum In: N Engl J Med. 2006 Mar 9;354(10):1102.
Results Reference
background
PubMed Identifier
8857069
Citation
Nikolaus T, Kruse W, Bach M, Specht-Leible N, Oster P, Schlierf G. Elderly patients' problems with medication. An in-hospital and follow-up study. Eur J Clin Pharmacol. 1996;49(4):255-9. doi: 10.1007/BF00226324.
Results Reference
background
PubMed Identifier
15341783
Citation
Thomas BJ, Finnin BC. The transdermal revolution. Drug Discov Today. 2004 Aug 15;9(16):697-703. doi: 10.1016/S1359-6446(04)03180-0.
Results Reference
background
PubMed Identifier
23862418
Citation
Shi Y, Wei Z, Zhao H, Liu T, Dong A, Zhang J. Electrospinning of ibuprofen-loaded composite nanofibers for improving the performances of transdermal patches. J Nanosci Nanotechnol. 2013 Jun;13(6):3855-63. doi: 10.1166/jnn.2013.7157.
Results Reference
background
PubMed Identifier
22972149
Citation
Derry S, Moore RA. Topical capsaicin (low concentration) for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD010111. doi: 10.1002/14651858.CD010111.
Results Reference
background
PubMed Identifier
23621015
Citation
Aggarwal N, Goindi S. Preparation and in vivo evaluation of solid lipid nanoparticles of griseofulvin for dermal use. J Biomed Nanotechnol. 2013 Apr;9(4):564-76. doi: 10.1166/jbn.2013.1569.
Results Reference
background
PubMed Identifier
23527660
Citation
Ahad A, Al-Jenoobi FI, Al-Mohizea AM, Aqil M, Kohli K. Transdermal delivery of calcium channel blockers for hypertension. Expert Opin Drug Deliv. 2013 Aug;10(8):1137-53. doi: 10.1517/17425247.2013.783562. Epub 2013 Mar 26.
Results Reference
background
PubMed Identifier
22011208
Citation
Goodman MP. Are all estrogens created equal? A review of oral vs. transdermal therapy. J Womens Health (Larchmt). 2012 Feb;21(2):161-9. doi: 10.1089/jwh.2011.2839. Epub 2011 Oct 19.
Results Reference
background
PubMed Identifier
19147237
Citation
Segal E, Zinman C, Raz B, Ish-Shalom S. Low patient compliance--a major negative factor in achieving vitamin D adequacy in elderly hip fracture patients supplemented with 800IU of vitamin D3 daily. Arch Gerontol Geriatr. 2009 Nov-Dec;49(3):364-7. doi: 10.1016/j.archger.2008.12.001. Epub 2009 Jan 14.
Results Reference
background
PubMed Identifier
19951084
Citation
Castelo-Branco C, Cortes X, Ferrer M; UNICAD study investigators. Treatment persistence and compliance with a combination of calcium and vitamin D. Climacteric. 2010 Dec;13(6):578-84. doi: 10.3109/13697130903452804. Epub 2009 Dec 1.
Results Reference
background
PubMed Identifier
19761279
Citation
Sanfelix-Genoves J, Gil-Guillen VF, Orozco-Beltran D, Giner-Ruiz V, Pertusa-Martinez S, Reig-Moya B, Carratala C. Determinant factors of osteoporosis patients' reported therapeutic adherence to calcium and/or vitamin D supplements: a cross-sectional, observational study of postmenopausal women. Drugs Aging. 2009;26(10):861-9. doi: 10.2165/11317070-000000000-00000.
Results Reference
background
PubMed Identifier
24711745
Citation
Sadat-Ali M, Bubshait DA, Al-Turki HA, Al-Dakheel DA, Al-Olayani WS. Topical delivery of vitamin d3: a randomized controlled pilot study. Int J Biomed Sci. 2014 Mar;10(1):21-4.
Results Reference
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Topical Delivery of Vitamin D3 as Vitamin D Supplementation

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