Evaluation of a Transdermal Vitamin D3 Delivery System, D3forME

NCT02174718 | Withdrawn DMC

• 1 other identifier: 2013-0766
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Cholecalciferol; Transdermal patch

Outcome Measures

Primary Outcomes (3)

• Serum 25(OH)D

  Change from baseline at 6 months

• Serum 25 OHD

  Change from baseline at 30 days

• Serum 25(OH)D

  Change from baseline at 4 months

Secondary Outcomes (1)

• Skin Erythema

  For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months

Other Outcomes (2)

• Body Fat

  During only the 2 and 3 phases, only at baseline visit.

• Serum Calcium

  For Pilot up to 30 days, For Efficacy up to 4 months, and For non-inferiority up to 6 months

Study Arms (5)

Daily 4000IU transdermal D patch

EXPERIMENTAL

Only in the stage 2, Efficacy Study

Dietary Supplement: Transdermal D Patch

Daily placebo patch plus oral placebo

ACTIVE COMPARATOR

Only in the stage 3, non-inferiority Study

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

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

Dietary Supplement: Transdermal D Patch; Dietary Supplement: Oral placebo

Daily transdermal placebo patch

PLACEBO COMPARATOR

Only in the stage 2, Efficacy Study

Dietary Supplement: Placebo patch

Interventions

Transdermal D Patch DIETARY_SUPPLEMENT

Daily 4000IU topical patch plus oral placebo; Daily 4000IU transdermal D patch

Oral vitamin D3 DIETARY_SUPPLEMENT

Also known as: Obtained from Tischon corporation

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Osteoporosis Clinical Research Program

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Neil Binkley, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 25, 2014
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 2, 2018

Record last verified: 2018-10

Locations

US (1)