Vitamin DNCT04851990
Assessment of the Safety & Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.
A study testing To Better Days Large Patch and To Better Days Small Patch in people with Vitamin D, run by Horopito Limited at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D
- What is being tested?
- To Better Days Large Patch and To Better Days Small Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 19 Apr 2021to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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).
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
- Sexual partner(s) is/are exclusively female.
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel Pilot Study to Assess the Safety and Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.
This is a pilot study to assess the safety and tolerability of long-term use of patented transdermal vitamin D patches in healthy adults.
Read the 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).
- Conditions
- Vitamin D
- Being tested
- To Better Days Large Patch, To Better Days Small Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To Better Days Large PatchOther
Large patch containing vitamin D \& Dextrose for transdermal absorption
To Better Days Small PatchOther
Small patch containing vitamin D \& Dextrose for transdermal absorption
| Study group | Role | What they receive |
|---|---|---|
| Large Patch | Experimental | To Better Days Large Patch
1 patch applied daily by 9am - in situ for 24 hours Dosage: vitamin D 30,000 IU + dextrose 13mg Receives: Other: To Better Days Large Patch |
| Small patch | Experimental | To Better Days Small Patch
1 patch applied daily by 9am - in situ for 24 hours Dosage: vitamin D 30,000 IU + dextrose 13mg Receives: Other: To Better Days Small Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to week 8
Number of treatment-emergent adverse event (TEAE) including causality, severity, and seriousness assessments.
Record number of TEAE per treatment arm
Measured: Baseline to 8 weeks
Number of participants with discontinuations due to AEs or TEAEs
Record any participants discontinued due to TEAE
Measured: Baseline to 8 weeks
Change in Full Blood Count
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood lipids - total cholesterol, HDL and LDL, triglycerides mmol/l
Monitor blood safety parameters
Measured: Baseline to week 8
Change in Liver Function Tests - IU/l - alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gama-glutamyl transferase
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood glucose mmol/l
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood bilirubin mg/dl
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood calcium mg/dl
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood protein g/l - total protein, albumin & globulin
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood creatine mg/dl
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood urea mg/dl
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood uric acid mg/dl
Monitor blood safety parameters
Measured: Baseline to week 8
Change in blood electrolytes mmol/l - sodium, potassium, chloride, bicarbonate, magnesium & phosphate
Monitor blood safety parameters
Measured: Baseline to week 8
Baseline Serum Vitamin D (25-OH) nmol/l
Monitor blood safety parameters
Measured: Baseline
Change in blood pressure - systolic blood pressure (mmHg) & diastolic blood pressure (mmHg)
Monitor safety measurements
Measured: Baseline to 8 weeks
Change in heart rate (BPM)
Monitor safety measurements
Measured: Baseline to 8 weeks
Change in body temperature (˚C)
Monitor safety measurements
Measured: Baseline to 8 weeks
Secondary outcomes (1)
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
Measured: Baseline - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start19 Apr 2021
- Primary completion16 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 Arms with 15 Subjects per group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horopito Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Principal investigator, Atlantia Food Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851990
- Sponsor's protocol ID
- AFCRO-135
- Status last verified
- Aug 2021
- First submitted
- 13 Apr 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jefferson A, Borges C. Evaluation of the safety, tolerability and plasma vitamin D response to long-term use of patented transdermal vitamin D patches in healthy adults: a randomised parallel pilot study. BMJ Nutr Prev Health. 2022 Jul 27;5(2):217-226. doi: 10.1136/bmjnph-2022-000471. eCollection 2022 Dec.
PubMed 36619342
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Pilot Study to Assess the Safety and Tolerability of Long-term Use of Patented Transdermal Patches in Healthy Adults.
- ClinicalTrials.gov ID
- NCT04851990
- Acronym / sponsor ID
- AFCRO-135
- Conditions
- Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Horopito LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the safety and tolerability of long-term use of patented transdermal vitamin D patches in healthy adults.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 Arms with 15 Subjects per group
| Arm | Type | Receives |
|---|---|---|
| Large Patch | Experimental | Other: To Better Days Large PatchTo Better Days Large Patch 1 patch applied daily by 9am - in situ for 24 hours Dosage: vitamin D 30,000 IU + dextrose 13mg |
| Small patch | Experimental | Other: To Better Days Small PatchTo Better Days Small Patch 1 patch applied daily by 9am - in situ for 24 hours Dosage: vitamin D 30,000 IU + dextrose 13mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To Better Days Large PatchLarge patch containing vitamin D \& Dextrose for transdermal absorption | Other | Large Patch |
| To Better Days Small PatchSmall patch containing vitamin D \& Dextrose for transdermal absorption | Other | Small patch |
Primary outcome
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
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
Number of participants with discontinuations due to AEs or TEAEs
Time frame: Baseline to 8 weeks
Record any participants discontinued due to TEAE
Change in Full Blood Count
Time frame: Baseline to week 8
Monitor blood safety parameters
Change in blood lipids - total cholesterol, HDL and LDL, triglycerides mmol/l
Time frame: Baseline to week 8
Monitor blood safety parameters
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
Change in blood glucose mmol/l
Time frame: Baseline to week 8
Monitor blood safety parameters
Change in blood bilirubin mg/dl
Time frame: Baseline to week 8
Monitor blood safety parameters
Change in blood calcium mg/dl
Time frame: Baseline to week 8
Monitor blood safety parameters
Change in blood protein g/l - total protein, albumin & globulin
Time frame: Baseline to week 8
Monitor blood safety parameters
Change in blood creatine mg/dl
Time frame: Baseline to week 8
Monitor blood safety parameters
Change in blood urea mg/dl
Time frame: Baseline to week 8
Monitor blood safety parameters
Change in blood uric acid mg/dl
Time frame: Baseline to week 8
Monitor blood safety parameters
Change in blood electrolytes mmol/l - sodium, potassium, chloride, bicarbonate, magnesium & phosphate
Time frame: Baseline to week 8
Monitor blood safety parameters
Baseline Serum Vitamin D (25-OH) nmol/l
Time frame: Baseline
Monitor blood safety parameters
Change in blood pressure - systolic blood pressure (mmHg) & diastolic blood pressure (mmHg)
Time frame: Baseline to 8 weeks
Monitor safety measurements
Change in heart rate (BPM)
Time frame: Baseline to 8 weeks
Monitor safety measurements
Change in body temperature (˚C)
Time frame: Baseline to 8 weeks
Monitor safety measurements
1 secondary outcome
Change in serum vitamin D levels, measured using at-home self-administered finger prick -nmol/l
Time frame: Baseline - 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Derived from this study: PubMed 36619342Jefferson A, Borges C. Evaluation of the safety, tolerability and plasma vitamin D response to long-term use of patented transdermal vitamin D patches in healthy adults: a randomised parallel pilot study. BMJ Nutr Prev Health. 2022 Jul 27;5(2):217-226. doi: 10.1136/bmjnph-2022-000471. eCollection 2022 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Dinan principal investigator
Atlantia Food Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To Better Days Large Patch and To Better Days Small Patch in people with Vitamin D, run by Horopito Limited at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing at least one treatment-emergent adverse event (TEAE) including causality, severity, and seriousness assessments. (time frame: Baseline to week 8). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.