Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Vitamin D Deficiency

In brief

A clinical need exists for non-oral vitamin D administration. This study is designed to test a new proprietary transdermal system. It is looking to see if this new system will safely and successfully deliver vitamin D3 to humans.

Key facts

Study ID

NCT02174718

Run by

University of Wisconsin, Madison

People needed

0

Starts

2015-11-01

Expected to finish

2017-11-01

Last updated by the study team

2018-11-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, community-dwelling ambulatory adults
• Able and willing to sign informed consent
• Age 18 to 75 years
• Baseline serum 25OHD concentration > 10 ng/mL and < 50 ng/mL
• Not pregnant
• Willing to not alter the amount of their baseline vitamin D supplementation during the course of this study
• Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected

You may not qualify if…

• Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism
• History of nephrolithiasis
• Baseline 24-hour urine calcium > 250 mg (female) or 300 mg (male)
• Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis
• History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma
• Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault approach) of ≤ 35 ml/minute
• Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study
• Treatment with any drug known to interfere with vitamin D metabolism, e.g., phenytoin, phenobarbital
• Known cutaneous sensitivity/allergy to tape or adhesives
• Known skin diseases, e.g., psoriasis, pemphigus, etc, which might alter transdermal vitamin D absorption
• Treatment with high dose vitamin D (≥ 50,000 IU weekly) or any active metabolites of vitamin D, e.g., calcitriol, within six months of screening
• Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer
• Planned trips/vacations likely to be associated with substantial amounts of sun exposure during the course of the study

Where it is running

• University of Wisconsin Osteoporosis Clinical Research Program — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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