Vitamin D Levels Following Topical Application of Vitamin D Ointment

• Status: Completed
• Trial end date: 2017-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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.