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Topical Delivery of Vitamin D3 as Vitamin D Supplementation

Straipsnius versti gali tik registruoti vartotojai
Prisijungti Registracija
Nuoroda įrašoma į mainų sritį
StatusasBaigta
Rėmėjai
Dammam University

Raktažodžiai

Santrauka

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.

apibūdinimas

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.

Datos

Paskutinį kartą patikrinta: 04/30/2017
Pirmasis pateikimas: 03/11/2016
Numatytas registravimas pateiktas: 04/05/2016
Pirmas paskelbtas: 04/11/2016
Paskutinis atnaujinimas pateiktas: 05/10/2017
Paskutinis atnaujinimas paskelbtas: 06/13/2017
Pirmųjų rezultatų pateikimo data: 01/27/2017
Pirmojo QC rezultatų pateikimo data: 05/10/2017
Pirmųjų paskelbtų rezultatų data: 06/13/2017
Faktinė studijų pradžios data: 03/31/2016
Numatoma pirminio užbaigimo data: 11/30/2016
Numatoma studijų užbaigimo data: 12/29/2016

Būklė ar liga

Vitamin D Deficiency

Intervencija / gydymas

Drug: Topical Vitamin D3 application

Other: Aloe vera gel Application

Fazė

Fazė 2

Rankų grupės

RankaIntervencija / gydymas
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

Tinkamumo kriterijai

Amžius, tinkami studijuoti 18 Years Į 18 Years
Tinkamos studijoms lytysAll
Priima sveikus savanoriusTaip
Kriterijai

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

Rezultatas

Pirminės rezultatų priemonės

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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