Topical Delivery of Vitamin D3 as Vitamin D Supplementation
Palavras-chave
Resumo
Descrição
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.
datas
| Última verificação: | 04/30/2017 |
| Enviado pela primeira vez: | 03/11/2016 |
| Inscrição estimada enviada: | 04/05/2016 |
| Postado pela primeira vez: | 04/11/2016 |
| Última atualização enviada: | 05/10/2017 |
| Última atualização postada: | 06/13/2017 |
| Data dos primeiros resultados enviados: | 01/27/2017 |
| Data dos primeiros resultados de QC enviados: | 05/10/2017 |
| Data dos primeiros resultados postados: | 06/13/2017 |
| Data real de início do estudo: | 03/31/2016 |
| Data Estimada de Conclusão Primária: | 11/30/2016 |
| Data Estimada de Conclusão do Estudo: | 12/29/2016 |
Condição ou doença
Intervenção / tratamento
Drug: Topical Vitamin D3 application
Other: Aloe vera gel Application
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| 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 |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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 |
Resultado
Medidas de Resultado Primário
1. Level of Serum 25 OHD Level Pre-treatment and Post Treatment [baseline and 5 months]
