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Vitamin D Levels Following Topical Application of Vitamin D Ointment (VITD-001)

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dose 1

Dose 2

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Minnesota Physicians - Phalen Village Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dose 1

Dose 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in vitamin D

Two sample paired t test of pre and post total serum 25-OH vitamin D level

Secondary Outcome Measures

Parathyroid hormone level

Two sample paired t test of pre and post total vitamin D level

Calcium level

Identification of any potential albumen adjusted hypercalcemia events

Skin irritation

Identification of any skin irritation events

Full Information

NCT ID

NCT02676674

First Posted

February 3, 2016

Last Updated

October 30, 2019

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT02676674

Brief Title

Vitamin D Levels Following Topical Application of Vitamin D Ointment

Acronym

VITD-001

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 Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

June 15, 2017 (Actual)

Study Completion Date

June 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Dose 2

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

Dose 1

Other Intervention Name(s)

cholecalciferol, 25-OH Vitamin D

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dose 2

Other Intervention Name(s)

cholecalciferol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in vitamin D

Description

Two sample paired t test of pre and post total serum 25-OH vitamin D level

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Parathyroid hormone level

Description

Two sample paired t test of pre and post total vitamin D level

Time Frame

4 weeks

Title

Calcium level

Description

Identification of any potential albumen adjusted hypercalcemia events

Time Frame

4 weeks

Title

Skin irritation

Description

Identification of any skin irritation events

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin A Peterson, MD, MPH

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota Physicians - Phalen Village Clinic

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19307527

Citation

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.

Results Reference

background

PubMed Identifier

12034416

Citation

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.

Results Reference

background

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Vitamin D Levels Following Topical Application of Vitamin D Ointment

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