Vitamin D Levels Following Topical Application of Vitamin D Ointment (VITD-001)
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|ClinicalTrials.gov Identifier: NCT02676674|
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Dose 1 Drug: Dose 2||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin D Levels in Subjects With Vitamin D Deficiency Following Topical Application of Three Doses of Vitamin D Ointment - A Proof of Concept Study|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||June 15, 2017|
|Actual Study Completion Date :||June 15, 2017|
Experimental: Dose 1
Three topical applications of 100,000 units for a total of 300,000 units of vitamin D3 in a newly formulated ointment will be applied to the upper arms over three weeks.
Drug: Dose 1
Subjects with vitamin D deficiency will be given 100,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21.
Experimental: Dose 2
Three topical applications of 300,000 units for a total of 900,000 units of vitamin D3 in a newly formulated ointment will be applied to the upper arms over three weeks.
Drug: Dose 2
Subjects with vitamin D deficiency will be given 300,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21.
Other Name: cholecalciferol
- Change in vitamin D [ Time Frame: 4 weeks ]Two sample paired t test of pre and post total serum 25-OH vitamin D level
- Parathyroid hormone level [ Time Frame: 4 weeks ]Two sample paired t test of pre and post total vitamin D level
- Calcium level [ Time Frame: 4 weeks ]Identification of any potential albumen adjusted hypercalcemia events
- Skin irritation [ Time Frame: 4 weeks ]Identification of any skin irritation events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676674
|United States, Minnesota|
|University of Minnesota Physicians - Phalen Village Clinic|
|Saint Paul, Minnesota, United States, 55106|
|Principal Investigator:||Kevin A Peterson, MD, MPH||University of Minnesota - Clinical and Translational Science Institute|