Topical Delivery of Vitamin D3 as Vitamin D Supplementation

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Vitamin D Deficiency

Clinical Trial Details

NCT number	NCT02735200
Study type	Interventional
Source	Dammam University
Contact	Mir Sadat-Ali, MS, FRCS
Phone	+966505848281
Email	drsadat@hotmail.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	April 2016
Completion date	January 2017

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Recruiting	`NCT05459298` - ViDES Trial (Vitamin D Extra Supplementation)	N/A
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT04476511` - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules	Phase 3
Completed	`NCT03920150` - Vitamin D 24'000 IU for Oral Intermittent Supplementation	Phase 3
Completed	`NCT03264625` - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis	Phase 2
Completed	`NCT04183257` - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics	Phase 4
Recruiting	`NCT05084248` - Vitamin D Deficiency in Adults Following a Major Burn Injury	Phase 4
Completed	`NCT05506696` - Vitamin D Supplementation Study	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Completed	`NCT03234218` - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed	`NCT02714361` - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women	N/A
Completed	`NCT02906319` - Vitamin D and HbA1c Levels in Diabetic Patients With CKD	N/A
Completed	`NCT03203382` - Corneal Nerve Structure in Sjogren's
Completed	`NCT02118129` - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.	N/A
Not yet recruiting	`NCT01419821` - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5	N/A
Completed	`NCT02275650` - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter	N/A
Completed	`NCT02187146` - The Effects of Serum Vitamin D and IVF Outcome	N/A
Completed	`NCT01651000` - Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency	Phase 3
Completed	`NCT01688102` - The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile	N/A