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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
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Tracking Information
First Submitted Date  ICMJE February 3, 2016
First Posted Date  ICMJE February 8, 2016
Last Update Posted Date May 7, 2019
Study Start Date  ICMJE March 2016
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
Change in vitamin D [ Time Frame: 4 weeks ]
Two sample paired t test of pre and post total serum 25-OH vitamin D level
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02676674 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Levels Following Topical Application of Vitamin D Ointment
Official Title  ICMJE Vitamin D Levels in Subjects With Vitamin D Deficiency Following Topical Application of Three Doses of Vitamin D Ointment - A Proof of Concept Study
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • 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.
    Other Names:
    • cholecalciferol
    • 25-OH Vitamin D
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Dose 1
  • 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.
    Intervention: Drug: Dose 2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2017)
10
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2016)
20
Actual Study Completion Date  ICMJE June 15, 2017
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Adult, age 18 to 85 years, male or female
  3. If on oral vitamin D therapy, have been on a stable dose for the previous 90 days.

Exclusion Criteria:

  1. 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.
  2. Hypercalcemia defined as either elevated corrected serum calcium >10.2 mg/dL) measured within 3 months prior to study.
  3. estimated glomerular filtration rate (eGFR) <60 mL/min within 3 months prior to study.
  4. Active cancers
  5. Women who are pregnant or breastfeeding.
  6. Individuals who are unable to give informed consent
  7. Individuals with psoriasis, active eczema or other skin disease, or who are currently receiving treatments or medications for skin disease.
  8. Individuals who do not agree to refrain from using tanning beds for the duration of the study.
  9. Individuals who do not agree to avoid submerging the ointment site in water for 8 hours after ointment application.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02676674
Other Study ID Numbers  ICMJE 24415
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor  ICMJE University of Minnesota - Clinical and Translational Science Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kevin A Peterson, MD, MPH University of Minnesota - Clinical and Translational Science Institute
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP