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Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME (D3forME)

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ClinicalTrials.gov Identifier: NCT02174718
Recruitment Status : Withdrawn (Due to manufacturing problems the transdermal patch was not produced.)
First Posted : June 25, 2014
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Transdermal D Patch Dietary Supplement: Oral vitamin D3 Dietary Supplement: Placebo patch Dietary Supplement: Oral placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Daily 4000IU transdermal D patch
Only in the stage 2, Efficacy Study
Dietary Supplement: Transdermal D Patch
Active Comparator: Daily placebo patch plus oral placebo
Only in the stage 3, non-inferiority Study
Dietary Supplement: Placebo patch
Dietary Supplement: Oral placebo
Active Comparator: Daily placebo patch plus oral vitamin D
Only in the stage 3 Non-inferiority Study
Dietary Supplement: Oral vitamin D3
Other Name: Obtained from Tischon corporation

Dietary Supplement: Placebo patch
Active Comparator: Daily 4000IU topical patch plus oral placebo
Only for the 3rd Stage of the study, Non-inferiority Study
Dietary Supplement: Transdermal D Patch
Dietary Supplement: Oral placebo
Placebo Comparator: Daily transdermal placebo patch
Only in the stage 2, Efficacy Study
Dietary Supplement: Placebo patch



Primary Outcome Measures :
  1. Serum 25(OH)D [ Time Frame: Change from baseline at 6 months ]
  2. Serum 25 OHD [ Time Frame: Change from baseline at 30 days ]
  3. Serum 25(OH)D [ Time Frame: Change from baseline at 4 months ]

Secondary Outcome Measures :
  1. Skin Erythema [ Time Frame: For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months ]
    Evaluate safety and skin tolerability of the D3forME topical supplement patch.


Other Outcome Measures:
  1. Body Fat [ Time Frame: During only the 2 and 3 phases, only at baseline visit. ]
    As an exploratory endpoint, the potential effect of body fat on response to daily D3forME topical supplement patches will be evaluated using DXA to measure body composition in the efficacy and non-inferiority studies.

  2. Serum Calcium [ Time Frame: For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174718


Locations
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United States, Wisconsin
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Neil Binkley, M.D. University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02174718    
Other Study ID Numbers: 2013-0766
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Keywords provided by University of Wisconsin, Madison:
Cholecalciferol
Transdermal patch
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents