- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02174718
Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME (D3forME)
Study Overview
Status
Conditions
Detailed Description
This will be conducted in 3 stages. The hypotheses of this work are as follows:
- The D3forME topical supplement patch will effectively and safely raise serum 25(OH)D3 in humans.
- The 25(OH)D3 increment with a daily 4,000 IU D3forME topical supplement patch will be superior to a placebo patch.
- The 25(OH)D3 increment with a daily 4,000 IU D3forME topical supplement patch will be non-inferior to that achieved with 4,000 IU of oral vitamin D3 daily.
- The 25(OH)D3 increase achieved with the D3forME topical supplement patch will not differ between young and older adults.
To test these hypotheses, this research will be conducted in three stages:
Stage 1: Open Label Proof of Concept Pilot Study. This study will document safety and tolerability of daily D3forME topical supplement patches containing 4,000 IU of vitamin D3 in 15 healthy adult men and women.
The specific aims of this study are to:
- Document the change in serum 25(OH)D3 with daily transdermal vitamin D3 dosing of 4,000 IU using the D3forME topical supplement patch.
- Evaluate safety and skin tolerability of the D3forME topical supplement patch.
Stage 2: Efficacy study. In this randomized, double blind placebo controlled study of four months duration involving 40 healthy adult men and women (n = 20 per group) the specific aims are to:
- Evaluate the safety and efficacy of daily D3forME topical supplement patches to increase serum 25(OH)D3.
- Determine if the 25(OH)D3 increase achieved by 4,000 IU of daily D3forME topical supplement patches is superior to placebo.
Stage 3: Non-inferiority study. In this randomized, double blind placebo controlled study of six months duration involving 220 healthy adult men and women in two age cohorts, (18-40 years and 65-85 years), the specific aims are to:
- Determine if the 25(OH)D3 increase achieved by 4,000 IU of daily D3forME topical supplement patches is not inferior to that achieved by 4,000 IU oral vitamin D3 supplementation.
- Assess if the 25(OH)D3 increase achieved by daily D3forME topical supplement patches differs between young and old adults.
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 (stages 2 and 3 above).
Open-label Proof of Concept Pilot Study. This open label study will evaluate the safety of a once daily D3forME topical supplement patches containing 4,000 IU of vitamin D3. Additionally, it will begin evaluating the efficacy of this approach on serum 25(OH)D3. This pilot study will include 15 healthy community dwelling men and women age 18-75 years without conditions contraindicating D supplementation or known skin conditions that could potentially interfere with cutaneous vitamin D3 delivery. Volunteers will be recruited from the Madison, WI area.
Stage 2: Randomized Double-blind, Placebo Controlled Efficacy Study: This study will include 40 adults (n = 20 in each group) using the same inclusion/exclusion criteria
Stage 3: Non-inferiority Study: This phase will include 220 adults randomly assigned to one of three treatment arms: n = 100 transdermal patch/placebo oral, n = 100 oral supplementation/placebo patch and n = 20 placebo oral and placebo patch) using the same inclusion/exclusion criteria as the noted above, except for age, which will be limited to 18-40 and 65-85. Additionally, each treatment arm will be equally divided into two cohorts, "young;" age 18-40 and "old;" age 65-85 years.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin Osteoporosis Clinical Research Program
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daily 4000IU transdermal D patch
Only in the stage 2, Efficacy Study
|
|
Active Comparator: Daily placebo patch plus oral placebo
Only in the stage 3, non-inferiority Study
|
|
Active Comparator: Daily placebo patch plus oral vitamin D
Only in the stage 3 Non-inferiority Study
|
Other Names:
|
Active Comparator: Daily 4000IU topical patch plus oral placebo
Only for the 3rd Stage of the study, Non-inferiority Study
|
|
Placebo Comparator: Daily transdermal placebo patch
Only in the stage 2, Efficacy Study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum 25(OH)D
Time Frame: Change from baseline at 6 months
|
Change from baseline at 6 months
|
Serum 25 OHD
Time Frame: Change from baseline at 30 days
|
Change from baseline at 30 days
|
Serum 25(OH)D
Time Frame: Change from baseline at 4 months
|
Change from baseline at 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During only the 2 and 3 phases, only at baseline visit.
|
Serum Calcium
Time Frame: For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months
|
For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0766
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vitamin D Deficiency
-
Federal University of Rio Grande do SulCompletedDeficiency, Vitamin DBrazil
-
University Hospital, Clermont-FerrandTerminated
-
Rajavithi HospitalQueen Sirikit National Institute of Child HealthCompleted
-
Universidade de Passo FundoUnknownDeficiency, Vitamin DBrazil
-
Nutrition Institute, SloveniaEuropean Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.CompletedVitamin B 12 Deficiency | Vitamin d Deficiency | Protein DeficiencySlovenia
-
Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionCompletedElderly, Frail | Deficiency, Vitamin DNetherlands
-
University of PaviaIstituti Clinici Scientifici Maugeri SpAUnknownVitamin D Deficiency | Vitamin D3 Deficiency | Vitamin DItaly
-
Okan UniversityArçelik A.Ş.Completed
-
Brigham and Women's HospitalCompletedVitamin d Deficiency
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingVitamin d DeficiencyChina
Clinical Trials on Transdermal D Patch
-
King's College LondonVitamax Wholesalers LLPRecruiting
-
Mundipharma Pte Ltd.Mundipharma Korea Ltd; Mundipharma (Hong Kong) Ltd; Mundipharma Distribution...CompletedOsteoarthritis | Rheumatoid Arthritis | Lower Back Pain | Joint Pain | Muscle PainHong Kong, Korea, Republic of, Philippines
-
Agile TherapeuticsCompleted
-
Cedars-Sinai Medical CenterTerminatedDehydration, Diverting Ileostomy, LoperamideUnited States
-
University of Maryland, BaltimoreFood and Drug Administration (FDA)Completed
-
UCB BIOSCIENCES GmbHCompleted
-
Izun Pharma LtdSuspendedGingival Inflammation in Diabetic PatientsIsrael
-
Vibe G Frøkjær, MD, PhDHvidovre University Hospital; Herlev HospitalRecruiting
-
James BOYD MDMichael J. Fox Foundation for Parkinson's Research; Philipps University Marburg... and other collaboratorsUnknownParkinson's DiseaseUnited States, Germany
-
The Cleveland ClinicTerminatedMild Cognitive Impairment | Mild Cognitive DisorderUnited States