This is a pilot study to assess the safety and tolerability of long-term use of patented transdermal vitamin D patches in healthy adults.
A randomised, parallel, pilot study to assess the safety and tolerability of long-term use of patented transdermal patches in healthy adults. The study consists of 4 on-site visits: the Screening Visit (Visit 1, Week -2), the Baseline Visit (Visit 2, Week 0), Visit 3 (Week 4), and the End of Intervention Visit (Week 8).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Large patch containing vitamin D \& Dextrose for transdermal absorption
Small patch containing vitamin D \& Dextrose for transdermal absorption
Atlantia Food Clinical Trials
Cork, Ireland
Number of participants experiencing at least one treatment-emergent adverse event (TEAE) including causality, severity, and seriousness assessments.
Record number of individual participants experiencing TEAE
Time frame: Baseline to week 8
Number of treatment-emergent adverse event (TEAE) including causality, severity, and seriousness assessments.
Record number of TEAE per treatment arm
Time frame: Baseline to 8 weeks
Number of participants with discontinuations due to AEs or TEAEs
Record any participants discontinued due to TEAE
Time frame: Baseline to 8 weeks
Change in Full Blood Count
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in blood lipids - total cholesterol, HDL and LDL, triglycerides mmol/l
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in Liver Function Tests - IU/l - alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gama-glutamyl transferase
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in blood glucose mmol/l
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in blood bilirubin mg/dl
Monitor blood safety parameters
Time frame: Baseline to week 8
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Change in blood calcium mg/dl
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in blood protein g/l - total protein, albumin & globulin
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in blood creatine mg/dl
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in blood urea mg/dl
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in blood uric acid mg/dl
Monitor blood safety parameters
Time frame: Baseline to week 8
Change in blood electrolytes mmol/l - sodium, potassium, chloride, bicarbonate, magnesium & phosphate
Monitor blood safety parameters
Time frame: Baseline to week 8
Baseline Serum Vitamin D (25-OH) nmol/l
Monitor blood safety parameters
Time frame: Baseline
Change in blood pressure - systolic blood pressure (mmHg) & diastolic blood pressure (mmHg)
Monitor safety measurements
Time frame: Baseline to 8 weeks
Change in heart rate (BPM)
Monitor safety measurements
Time frame: Baseline to 8 weeks
Change in body temperature (˚C)
Monitor safety measurements
Time frame: Baseline to 8 weeks
Change in serum vitamin D levels, measured using at-home self-administered finger prick -nmol/l
Measure change to plasma vitamin D in response to daily patch application
Time frame: Baseline - 8 weeks