- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02676674
Vitamin D Levels Following Topical Application of Vitamin D Ointment (VITD-001)
October 30, 2019 updated by: University of Minnesota
Vitamin D Levels in Subjects With Vitamin D Deficiency Following Topical Application of Three Doses of Vitamin D Ointment - A Proof of Concept Study
This is a pre-post open label trial to assess the change in Vitamin D blood levels following treatment with three doses of topical Vitamin D3 in subjects with existing Vitamin D deficiency.
Study Overview
Detailed Description
The proposed study investigates safety and efficacy of a new topical vitamin D3 compound.
The purpose of this Phase 1 trial is to determine whether topical application makes Vitamin D bioavailable to the systemic circulation in sufficient quantities to treat hypovitaminosis D. The study will assess the change in serum 25-hydroxy (25-OH) vitamin D concentrations following 3 doses of 100,000 IU or 3 doses of 300,000 IU of topical vitamin D3 ointment in volunteers with vitamin D deficiency.
Adults with serum 25-OH vitamin D concentrations of < 20 ng/ml will receive a total of 300,000 IU or 900,000 IU in divided doses of topical vitamin D once per week for three weeks.
Two 0.75 ml applicators of ointment will be applied to each upper arm (50,000 IU or 150,000 IU per arm) by study staff.
Blood will be drawn at baseline prior to the first dose (Day 0) and on Days 7, 14, and 21.
Total serum 25-OH vitamin D will be assayed at each draw.
Parathyroid hormone, a measure of clinical effects of low vitamin D levels, will be checked at baseline and on day 21.
Serum albumin adjusted calcium levels will be checked with each draw to check for possible effects of too much vitamin D absorption.
The study will determine whether the topical application of Vitamin D ointment is able to correct existing vitamin D deficiency.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Saint Paul, Minnesota, United States, 55106
- University of Minnesota Physicians - Phalen Village Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Known vitamin D deficiency based on blood work obtained prior to study consent defined as serum 25-hydroxyvitamin D less than or equal to 20 ng/mL within 30 days prior to study entry.
- Adult, age 18 to 85 years, male or female
- If on oral vitamin D therapy, have been on a stable dose for the previous 90 days.
Exclusion Criteria:
- History of chronic liver disease with elevated liver function tests, chronic kidney disease (stage 3 or greater, eGFR <60 mL/min), uncontrolled thyroid disease (elevated thyroid function tests), primary or secondary hyperparathyroidism, hypercalcemia, or multiple endocrine neoplasia.
- Hypercalcemia defined as either elevated corrected serum calcium >10.2 mg/dL) measured within 3 months prior to study.
- estimated glomerular filtration rate (eGFR) <60 mL/min within 3 months prior to study.
- Active cancers
- Women who are pregnant or breastfeeding.
- Individuals who are unable to give informed consent
- Individuals with psoriasis, active eczema or other skin disease, or who are currently receiving treatments or medications for skin disease.
- Individuals who do not agree to refrain from using tanning beds for the duration of the study.
- Individuals who do not agree to avoid submerging the ointment site in water for 8 hours after ointment application.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
Other Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vitamin D
Time Frame: 4 weeks
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Two sample paired t test of pre and post total serum 25-OH vitamin D level
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parathyroid hormone level
Time Frame: 4 weeks
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Two sample paired t test of pre and post total vitamin D level
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4 weeks
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Calcium level
Time Frame: 4 weeks
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Identification of any potential albumen adjusted hypercalcemia events
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4 weeks
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Skin irritation
Time Frame: 4 weeks
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Identification of any skin irritation events
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin A Peterson, MD, MPH, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ginde AA, Liu MC, Camargo CA Jr. Demographic differences and trends of vitamin D insufficiency in the US population, 1988-2004. Arch Intern Med. 2009 Mar 23;169(6):626-32. doi: 10.1001/archinternmed.2008.604.
- Tangpricha V, Pearce EN, Chen TC, Holick MF. Vitamin D insufficiency among free-living healthy young adults. Am J Med. 2002 Jun 1;112(8):659-62. doi: 10.1016/s0002-9343(02)01091-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
June 15, 2017
Study Completion (Actual)
June 15, 2017
Study Registration Dates
First Submitted
February 3, 2016
First Submitted That Met QC Criteria
February 3, 2016
First Posted (Estimate)
February 8, 2016
Study Record Updates
Last Update Posted (Actual)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 602M84081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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