Vitamin D DeficiencyD3forMENCT02174718
Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME
A study testing Transdermal D Patch and Oral vitamin D3 in people with Vitamin D Deficiency, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Transdermal D Patch and Oral vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, 53705
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Transdermal D Patch, Oral vitamin D3, Placebo patch, Oral placebo
- Keywords
- Cholecalciferol, Transdermal patch
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal D PatchDietary supplement
Oral vitamin D3Dietary supplement
Also called Obtained from Tischon corporation
Placebo patchDietary supplement
Oral placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Daily 4000IU transdermal D patch | Experimental | Only in the stage 2, Efficacy Study Receives: Dietary Supplement: Transdermal D Patch |
| Daily placebo patch plus oral placebo | Active comparator | Only in the stage 3, non-inferiority Study Receives: Dietary Supplement: Placebo patch; Dietary Supplement: Oral placebo |
| Daily placebo patch plus oral vitamin D | Active comparator | Only in the stage 3 Non-inferiority Study Receives: Dietary Supplement: Oral vitamin D3; Dietary Supplement: Placebo patch |
| Daily 4000IU topical patch plus oral placebo | Active comparator | Only for the 3rd Stage of the study, Non-inferiority Study Receives: Dietary Supplement: Transdermal D Patch; Dietary Supplement: Oral placebo |
| Daily transdermal placebo patch | Placebo comparator | Only in the stage 2, Efficacy Study Receives: Dietary Supplement: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D
Measured: Change from baseline at 6 months
Serum 25 OHD
Measured: Change from baseline at 30 days
Serum 25(OH)D
Measured: Change from baseline at 4 months
Secondary outcomes (1)
Skin Erythema
Evaluate safety and skin tolerability of the D3forME topical supplement patch.
Measured: For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Due to manufacturing problems the transdermal patch was not produced.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Binkley, M.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174718
- Sponsor's protocol ID
- 2013-0766
- Acronym
- D3forME
- Status last verified
- Oct 2018
- First submitted
- 18 Jun 2014
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME
- ClinicalTrials.gov ID
- NCT02174718
- Acronym / sponsor ID
- D3forME / 2013-0766
- Conditions
- Vitamin D Deficiency
- Keywords
- Cholecalciferol, Transdermal patch
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to manufacturing problems the transdermal patch was not produced.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Daily 4000IU transdermal D patch | Experimental | Dietary Supplement: Transdermal D PatchOnly in the stage 2, Efficacy Study |
| Daily placebo patch plus oral placebo | Active comparator | Dietary Supplement: Placebo patch, Dietary Supplement: Oral placeboOnly in the stage 3, non-inferiority Study |
| Daily placebo patch plus oral vitamin D | Active comparator | Dietary Supplement: Oral vitamin D3, Dietary Supplement: Placebo patchOnly in the stage 3 Non-inferiority Study |
| Daily 4000IU topical patch plus oral placebo | Active comparator | Dietary Supplement: Transdermal D Patch, Dietary Supplement: Oral placeboOnly for the 3rd Stage of the study, Non-inferiority Study |
| Daily transdermal placebo patch | Placebo comparator | Dietary Supplement: Placebo patchOnly in the stage 2, Efficacy Study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal D Patch | Dietary supplement | Daily 4000IU topical patch plus oral placebo, Daily 4000IU transdermal D patch |
| Oral vitamin D3Also: Obtained from Tischon corporation | Dietary supplement | Daily placebo patch plus oral vitamin D |
| Placebo patch | Dietary supplement | Daily placebo patch plus oral placebo, Daily placebo patch plus oral vitamin D, Daily transdermal placebo patch |
| Oral placebo | Dietary supplement | Daily 4000IU topical patch plus oral placebo, Daily placebo patch plus oral placebo |
Primary outcome
Serum 25(OH)D
Time frame: Change from baseline at 6 months
Serum 25 OHD
Time frame: Change from baseline at 30 days
Serum 25(OH)D
Time frame: Change from baseline at 4 months
1 secondary outcome
Skin Erythema
Time frame: For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Binkley, M.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal D Patch and Oral vitamin D3 in people with Vitamin D Deficiency, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH)D (time frame: Change from baseline at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.