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Assessment of the Safety & Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.

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ClinicalTrials.gov Identifier: NCT04851990
Recruitment Status : Completed
First Posted : April 21, 2021
Last Update Posted : August 5, 2021
Sponsor:
Collaborator:
Atlantia Food Clinical Trials
Information provided by (Responsible Party):
Horopito Limited

Study Description
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Brief Summary:
This is a pilot study to assess the safety and tolerability of long-term use of patented transdermal vitamin D patches in healthy adults.

Condition or disease Intervention/treatment Phase
Vitamin D Other: To Better Days Large Patch Other: To Better Days Small Patch Not Applicable

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 Arms with 15 Subjects per group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Parallel Pilot Study to Assess the Safety and Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.
Actual Study Start Date : April 19, 2021
Actual Primary Completion Date : July 16, 2021
Actual Study Completion Date : July 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Experimental: Large Patch

To Better Days Large Patch

1 patch applied daily by 9am - in situ for 24 hours Dosage: vitamin D 30,000 IU + dextrose 13mg

 Other: To Better Days Large Patch
Large patch containing vitamin D & Dextrose for transdermal absorption
Experimental: Small patch

To Better Days Small Patch

1 patch applied daily by 9am - in situ for 24 hours Dosage: vitamin D 30,000 IU + dextrose 13mg

 Other: To Better Days Small Patch
Small patch containing vitamin D & Dextrose for transdermal absorption


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants experiencing at least one treatment-emergent adverse event (TEAE) including causality, severity, and seriousness assessments. [ Time Frame: Baseline to week 8 ]
    Record number of individual participants experiencing TEAE

  2. Number of treatment-emergent adverse event (TEAE) including causality, severity, and seriousness assessments. [ Time Frame: Baseline to 8 weeks ]
    Record number of TEAE per treatment arm

  3. Number of participants with discontinuations due to AEs or TEAEs [ Time Frame: Baseline to 8 weeks ]
    Record any participants discontinued due to TEAE

  4. Change in Full Blood Count [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  5. Change in blood lipids - total cholesterol, HDL and LDL, triglycerides mmol/l [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  6. Change in Liver Function Tests - IU/l - alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gama-glutamyl transferase [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  7. Change in blood glucose mmol/l [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  8. Change in blood bilirubin mg/dl [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  9. Change in blood calcium mg/dl [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  10. Change in blood protein g/l - total protein, albumin & globulin [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  11. Change in blood creatine mg/dl [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  12. Change in blood urea mg/dl [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  13. Change in blood uric acid mg/dl [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  14. Change in blood electrolytes mmol/l - sodium, potassium, chloride, bicarbonate, magnesium & phosphate [ Time Frame: Baseline to week 8 ]
    Monitor blood safety parameters

  15. Baseline Serum Vitamin D (25-OH) nmol/l [ Time Frame: Baseline ]
    Monitor blood safety parameters

  16. Change in blood pressure - systolic blood pressure (mmHg) & diastolic blood pressure (mmHg) [ Time Frame: Baseline to 8 weeks ]
    Monitor safety measurements

  17. Change in heart rate (BPM) [ Time Frame: Baseline to 8 weeks ]
    Monitor safety measurements

  18. Change in body temperature (˚C) [ Time Frame: Baseline to 8 weeks ]
    Monitor safety measurements


Secondary Outcome Measures :
  1. Change in serum vitamin D levels, measured using at-home self-administered finger prick -nmol/l [ Time Frame: Baseline - 8 weeks ]
    Measure change to plasma vitamin D in response to daily patch application


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Individuals who are willing to participate in the study and comply with its procedures.

    2. Individuals who are able to give written informed consent. 3. Individuals between 18-70 years old. 4. Has a BMI between 18-32 kg/m2 (inclusive). 5. Individuals who are willing to not undertake overseas travel for the duration of the study or engage in excessive sun-exposure or use of sun lamps or tanning beds for the duration of the study.

    6. Individuals who are willing to maintain their current diet and not change supplement usage for the duration of the study.

    7. Individuals who are willing to self-administer finger prick sampling. 8. Individuals who are willing to avoid strenuous exercise or exposing the patch to external sources of direct heat e.g., heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight, while wearing the patch.

    9. Individuals willing to refrain from swimming or other sports involving immersion in water for the duration of the study.

    10. Individuals who have Serum 25-Hydroxyvitamin D concentration of ≥15 nmol/L and ≤100 nmol/L at screening.

Exclusion Criteria:

  • 1. Are less than 18 or greater than 70 years old. 2. Participants who are pregnant, breastfeeding, or wish to become pregnant during the study.

    3. Individuals currently of childbearing potential, but not using an effective method of contraception, as outlined below:

    1. Complete abstinence from intercourse two weeks prior to administration of Investigational Product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the Investigational Product in cases where participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
    2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
    3. Sexual partner(s) is/are exclusively female.
    4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 2 weeks prior to use of the Investigational Product and at least 1 week following the end of the study.

    5. Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the study, and 2 weeks following the end of the study.

      4. Individuals who are hypersensitive to any of the components of the investigational product.

      5. Individuals who have a condition affecting the integrity of the skin (e.g., psoriasis or eczema).

      6. Individuals who are taking, or have taken, any prescribed or over the counter (OTC) drug and antacids, supplements, or herbal remedies in the 14 days before patch administration including any drugs known to interfere with vitamin D metabolism (e.g., steroids, orlistat, cholestyramine, phenytoin, statins, thiazide diuretics etc.). Occasional use of paracetamol up to a maximum of 2 g per day, hormone replacement therapy [HRT] or hormonal contraception are permissible.

      7. Individuals who have taken calcium supplements within the previous 8 weeks. 8. Individuals who are taking vitamin D supplements greater than 10 micrograms per day.

      9. Individuals with any history of or concurrent clinically significant diseases or conditions (e.g., kidney or liver dysfunction).

      10. Individuals with a known history of allergy to plasters or patches. 11. Individuals who have planned major changes in lifestyle (i.e., diet, dieting, exercise level, travelling) during the duration of the study

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851990


Locations
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Ireland
Atlantia Food Clinical Trials
Cork, Ireland
Sponsors and Collaborators
Horopito Limited
Atlantia Food Clinical Trials
Investigators
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Principal Investigator: Timothy Dinan Atlantia Food Clinical Trials
More Information
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Responsible Party: Horopito Limited
ClinicalTrials.gov Identifier: NCT04851990    
Other Study ID Numbers: AFCRO-135
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No