Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Serum 25(OH)D
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Daily placebo patch plus oral vitamin D
Only in the stage 3 Non-inferiority Study
干预措施: Oral vitamin D3 (Dietary Supplement)
Daily placebo patch plus oral vitamin D
Only in the stage 3 Non-inferiority Study
干预措施: Placebo patch (Dietary Supplement)
Daily 4000IU topical patch plus oral placebo
Only for the 3rd Stage of the study, Non-inferiority Study
干预措施: Transdermal D Patch (Dietary Supplement)
Daily 4000IU transdermal D patch
Only in the stage 2, Efficacy Study
干预措施: Transdermal D Patch (Dietary Supplement)
Daily placebo patch plus oral placebo
Only in the stage 3, non-inferiority Study
干预措施: Placebo patch (Dietary Supplement)
Daily placebo patch plus oral placebo
Only in the stage 3, non-inferiority Study
干预措施: Oral placebo (Dietary Supplement)
Daily 4000IU topical patch plus oral placebo
Only for the 3rd Stage of the study, Non-inferiority Study
干预措施: Oral placebo (Dietary Supplement)
Daily transdermal placebo patch
Only in the stage 2, Efficacy Study
干预措施: Placebo patch (Dietary Supplement)
结局指标
主要结局
Serum 25(OH)D
时间窗: Change from baseline at 4 months
Serum 25 OHD
时间窗: Change from baseline at 30 days
次要结局
- Skin Erythema(For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months)