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Topical Delivery of Vitamin D3 as Vitamin D Supplementation

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StatusLengkap
Sponsor
Dammam University

Kata kunci

Abstrak

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.

Deskripsi

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.

tanggal

Terakhir Diverifikasi: 04/30/2017
Pertama Dikirim: 03/11/2016
Perkiraan Pendaftaran Telah Dikirim: 04/05/2016
Pertama Diposting: 04/11/2016
Pembaruan Terakhir Dikirim: 05/10/2017
Pembaruan Terakhir Diposting: 06/13/2017
Tanggal hasil pengiriman pertama: 01/27/2017
Tanggal hasil QC pertama kali dikirim: 05/10/2017
Tanggal hasil posting pertama: 06/13/2017
Tanggal Mulai Studi Sebenarnya: 03/31/2016
Perkiraan Tanggal Penyelesaian Utama: 11/30/2016
Perkiraan Tanggal Penyelesaian Studi: 12/29/2016

Kondisi atau penyakit

Vitamin D Deficiency

Intervensi / pengobatan

Drug: Topical Vitamin D3 application

Other: Aloe vera gel Application

Tahap

Tahap 2

Kelompok Lengan

LenganIntervensi / pengobatan
Experimental: Topical Vitamin D3 application
Intervention is Application of topical Vitamin D3 Frequency: Daily Dosage: 1 gram (5000 IU) Duration: 120 days
Drug: Topical Vitamin D3 application
Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days
Active Comparator: Aloe vera gel Application
Application of Aloe vera gel will be carried out Dosage: 1 gram Frequency: Daily Duration: 120 days
Other: Aloe vera gel Application
aloe vera gel will be applied Dosage: 1 gram Duration: 120 days Frequency: Daily

Kriteria kelayakan

Usia yang Layak untuk Belajar 18 Years Untuk 18 Years
Jenis Kelamin yang Layak untuk BelajarAll
Menerima Relawan SehatIya
Kriteria

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

Hasil

Ukuran Hasil Utama

1. Level of Serum 25 OHD Level Pre-treatment and Post Treatment [baseline and 5 months]

Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.

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