Topical Delivery of Vitamin D3 as Vitamin D Supplementation

Vitamin D Deficiency Clinical Trial

Official title:

Topical Delivery of Vitamin D3: A Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02735200
• Other study ID #: DammamU
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 12, 2016
• Last updated: January 23, 2017
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Dammam University
• Contact: Mir Sadat-Ali, MS, FRCS
• Phone: +966505848281
• Email: drsadat[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• topical vitamin D3 in intervention group
local application

Locations

Country	Name	City	State
Saudi Arabia	King Fahd Hospital of the University	AlKhobar

Sponsors (1)

Lead Sponsor	Collaborator
Dammam University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (18)

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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. — View 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. — View Citation

Sanfelix-Genovés J, Gil-Guillén VF, Orozco-Beltran D, Giner-Ruiz V, Pertusa-Martínez S, Reig-Moya B, Carratalá 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. — View 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. — View 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. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the serum levels of 25OHD after 4 months of treatment with topical Vitamin D3.		4 months