Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT02174718
Status:
WITHDRAWN
Last Update Posted:
2018-11-02
First Post:
2014-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to manufacturing problems the transdermal patch was not produced.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
D3forME
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.
Detailed Description:
This will be conducted in 3 stages. The hypotheses of this work are as follows:
1. The D3forME topical supplement patch will effectively and safely raise serum 25(OH)D3 in humans.
2. The 25(OH)D3 increment with a daily 4,000 IU D3forME topical supplement patch will be superior to a placebo patch.
3. 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.
4. 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:
1. Document the change in serum 25(OH)D3 with daily transdermal vitamin D3 dosing of 4,000 IU using the D3forME topical supplement patch.
2. 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:
1. Evaluate the safety and efficacy of daily D3forME topical supplement patches to increase serum 25(OH)D3.
2. 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:
1. 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.
2. 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.
1. The D3forME topical supplement patch will effectively and safely raise serum 25(OH)D3 in humans.
2. The 25(OH)D3 increment with a daily 4,000 IU D3forME topical supplement patch will be superior to a placebo patch.
3. 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.
4. 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:
1. Document the change in serum 25(OH)D3 with daily transdermal vitamin D3 dosing of 4,000 IU using the D3forME topical supplement patch.
2. 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:
1. Evaluate the safety and efficacy of daily D3forME topical supplement patches to increase serum 25(OH)D3.
2. 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:
1. 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.
2. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: