Vitamin D SupplementationTransVitDNCT06098846
Human Transdermal Vitamin D Supplement Study
A study testing Vitamin D phosphate in people with Vitamin D Supplementation, run by King's College London at 1 site in United Kingdom.
Trial summary
Despite the wide availability of vitamin D supplements vitamin D deficiency remains a concerning global problem. It is hypothesised that hypothesize that vitamin D delivered via the skin will overcome the problems associated with variable oral bioavailability and lead to a patient-friendly and efficacious means to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Supplementation
- What is being tested?
- Vitamin D phosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2023to 10 Sep 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults between 18 and 65 years of age
- Suspected low vitamin D levels (defined as moderate or high risk using the Deschasaux questionnaire (10))
- Written informed consent for study participation.
- Willingness to comply with all study requirements.
- Competent use of English language.
Who cannot join
- Patients unable to give informed consent.
- The use of vitamin D supplements 4 weeks prior to the commencement of the study (and unwilling to washout).
- Pregnancy
- Those with parathyroid, thyroid, or calcium disorders, sarcoidosis, a requirement for calcium channel blockers, Type I diabetes, and concurrent active malignancies.
- Those who have been diagnosed with vitamin D deficiency by a GP in the last 3 months using a blood test.
- Those who have been diagnosed with vitamin D deficiency by a GP in the last 6 months using a blood test and have not taken any vitamin D supplements.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Pharmaceutical Science, King's College London
London, London, SE19NH
About this study
Official title: Double-Blind Placebo-Controlled Human Transdermal Vitamin D Supplement Study
Despite the wide availability of vitamin D supplements vitamin D deficiency remains a concerning global problem. It is hypothesised that hypothesize that vitamin D delivered via the skin will overcome the problems associated with variable oral bioavailability and lead to a patient-friendly and efficacious means to supplement this vitamin. The main objective of this study is therefore to test the efficacy of a vitamin D transdermal patch that employs vitamin D phosphate to deliver the vitamin D into the blood.
In this two-part supplementation study healthy individuals with a risk of vitamin D deficiency (n=118), aged between 18 - 65 years, will be recruited. The recruitment in central London, UK, will ensure a multicultural, multi-ethnic cohort to enable the findings to be translated into evidence to try and find a solution for the global vitamin D deficiency problem.
Read the detailed description
The primary objective of this study is to understand the ability of a vitamin D transdermal patch to provide effective vitamin D supplementation. To do this, the study team will identify, using a questionnaire (validated collection tool), a cohort of healthy individuals who are at risk of vitamin D deficiency. The study team will take the personal details of the volunteers, a full medical history, food, exercise, body indices, and diet information and register these details. A baseline assessment will be taken of those patients who are identified by the questionnaire as likely to have low vitamin D levels and meet the study inclusion and exclusion criteria. The baseline measurements will include a blood sample to determine 25(OH)vitamin D3 (25(OH)VD3) concentration in the serum (perhaps also other metabolites), vitamin D binding protein (VDBP) concentrations in the blood serum and the skin interstitial fluid, parathyroid hormone levels and calcium in the blood. It will also require images of the human nails. This information will help to understand the vitamin D status of each study participant. This baseline data will be uploaded to a secure database and form the basic demographic information and baseline levels prior to the application of the vitamin D supplement patch.
The supplementation study will take 2 parts. In part one, two cohorts of 8 participants will be provided with one of two doses of the supplement in a dose escalation pilot study. These cohorts will be supplemented in sequence to establish the safety of the dose, with the lowest dose being confirmed to be safe prior to the second dose being tested. The primary outcome will be safety and tolerability. A calcium measure of more than 12 mg/dL or 25(OH)VD3 > 150 nM/L will indicate a risk of toxicity at the 2-week or 4-week blood draw and the dosing would terminate and this would be considered as a serious adverse event. If there are serious adverse events in 2 or more of the participants the dose will not be safe. The secondary outcome will be efficacy, and a change of 25(OH)VD3 of less than 5 nM/L in more than 75% of participants would indicate the dose is ineffective after 4 weeks and this will be used to guide the second cohort dosing.
Upon completion of part 1 the second part will begin. In part 2, the participants will be randomized by a statistician into 4 interventional arms, one placebo, and 3 different patch dosing frequencies. In part 2, the study will last 8 weeks with measurements at weeks 4 and 8. Part 2 will have an interim analysis at week 4, then it will proceed with only 2 study arms and make final measurements on week 8. The dosing for part 2 in the different arms of the study will be based on the part 1 results. The aim of these two studies is to establish if vitamin D supplementation via the skin improves the vitamin D status and at what dosing level/interval is required to achieve this.
- Conditions
- Vitamin D Supplementation
- Being tested
- Vitamin D phosphate, Placebo transdermal patch
- Keywords
- vitamin D, supplementation, transdermal patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D phosphateDietary supplement
Application of a Vitamin D phosphate active patch
Placebo transdermal patchDietary supplement
Application of a placebo transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| Placebo patch | Placebo comparator | Placebo transdermal patch daily Receives: Dietary Supplement: Placebo transdermal patch |
| Dose Frequency 1 | Active comparator | Active transdermal patch daily (actives could be alternated with placebo in a given sequence) Receives: Dietary Supplement: Vitamin D phosphate |
| Dose Frequency 2 | Active comparator | Active transdermal patch daily (actives could be alternated with placebo in a given sequence) Receives: Dietary Supplement: Vitamin D phosphate |
| Dose Frequency 3 | Active comparator | Active transdermal patch daily (actives could be alternated with placebo in a given sequence) Receives: Dietary Supplement: Vitamin D phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the % change in 25(OH)vitamin D3 concentration in human serum compared to baseline
Concentration of 25(OH)vitamin in the serum (ng/ml)
Measured: After 4 and 8 weeks compared to baseline
Secondary outcomes (3)
Measurement of the % change in vitamin D binding protein concentration in human serum compared to baseline
Concentration of vitamin D binding protein levels in the serum (micrograms per ml)
Measured: After 4 and 8 weeks compared to baseline
Measurement % of chemical biomarker concentrations in the human skin interstitial fluid compared to baseline
Concentration change of chemicals identified in skin interstitial fluid (ng/ml)
Measured: 4 and 8 weeks compared to baseline
Measurement of the change in human nail plate characteristics measured using pixels compared to baseline
Quantification of image feature change in nail photographs (unit pixels)
Measured: 4 and 8 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start23 Oct 2023
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D SupplementationStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Vitamax Wholesalers LLP
- Responsible party
- Sponsor
- Investigators
- Stuart Jones, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098846
- Sponsor's protocol ID
- HR/DP-22/23-34078
- Acronym
- TransVitD
- Status last verified
- Sep 2023
- First submitted
- 5 Oct 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kawashita M, Lim CH, Hibbard T, Andriollo P, Li Y, Lawrence KP, John E, Royall PR, Guo Q, Tasdemir D, Ayrton O, Fitzgerald O'Connor E, Benaouda F, Bashir S, Cilibrizzi A, Luebcke P, Young AR, Douiri A, O'Shaughnessy R, Carpenter G, Alhnan M, Jones SA. A UV-Free Strategy for Vitamin D Synthesis in Skin: Concept Verification and a Randomised Double-Blind Placebo-Controlled Clinical Trial of a Cholecalciferol Phosphate Patch (TransVitD). Br J Dermatol. 2026 Oct 1:ljag421. doi: 10.1093/bjd/ljag421. Online ahead of print.
PubMed 42817826Hibbard T, Andriollo P, Lim CH, Guo Q, Lawrence KP, Coker B, Malek R, Douiri A, Alhnan MA, Jones SA. A multistage double-blind placebo-controlled study to assess the safety and efficacy of transdermal vitamin D phosphate supplementation (TransVitD). Trials. 2025 Feb 19;26(1):59. doi: 10.1186/s13063-024-08711-8.
PubMed 39972355
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Placebo-Controlled Human Transdermal Vitamin D Supplement Study
- ClinicalTrials.gov ID
- NCT06098846
- Acronym / sponsor ID
- TransVitD / HR/DP-22/23-34078
- Conditions
- Vitamin D Supplementation
- Keywords
- vitamin D, supplementation, transdermal patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Vitamax Wholesalers LLP
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 25 Oct 2023 (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.
Despite the wide availability of vitamin D supplements vitamin D deficiency remains a concerning global problem. It is hypothesised that hypothesize that vitamin D delivered via the skin will overcome the problems associated with variable oral bioavailability and lead to a patient-friendly and efficacious means to supplement this vitamin. The main objective of this study is therefore to test the efficacy of a vitamin D transdermal patch that employs vitamin D phosphate to deliver the vitamin D into the blood.
In this two-part supplementation study healthy individuals with a risk of vitamin D deficiency (n=118), aged between 18 - 65 years, will be recruited. The recruitment in central London, UK, will ensure a multicultural, multi-ethnic cohort to enable the findings to be translated into evidence to try and find a solution for the global vitamin D deficiency problem.
Detailed description
The primary objective of this study is to understand the ability of a vitamin D transdermal patch to provide effective vitamin D supplementation. To do this, the study team will identify, using a questionnaire (validated collection tool), a cohort of healthy individuals who are at risk of vitamin D deficiency. The study team will take the personal details of the volunteers, a full medical history, food, exercise, body indices, and diet information and register these details. A baseline assessment will be taken of those patients who are identified by the questionnaire as likely to have low vitamin D levels and meet the study inclusion and exclusion criteria. The baseline measurements will include a blood sample to determine 25(OH)vitamin D3 (25(OH)VD3) concentration in the serum (perhaps also other metabolites), vitamin D binding protein (VDBP) concentrations in the blood serum and the skin interstitial fluid, parathyroid hormone levels and calcium in the blood. It will also require images of the human nails. This information will help to understand the vitamin D status of each study participant. This baseline data will be uploaded to a secure database and form the basic demographic information and baseline levels prior to the application of the vitamin D supplement patch.
The supplementation study will take 2 parts. In part one, two cohorts of 8 participants will be provided with one of two doses of the supplement in a dose escalation pilot study. These cohorts will be supplemented in sequence to establish the safety of the dose, with the lowest dose being confirmed to be safe prior to the second dose being tested. The primary outcome will be safety and tolerability. A calcium measure of more than 12 mg/dL or 25(OH)VD3 > 150 nM/L will indicate a risk of toxicity at the 2-week or 4-week blood draw and the dosing would terminate and this would be considered as a serious adverse event. If there are serious adverse events in 2 or more of the participants the dose will not be safe. The secondary outcome will be efficacy, and a change of 25(OH)VD3 of less than 5 nM/L in more than 75% of participants would indicate the dose is ineffective after 4 weeks and this will be used to guide the second cohort dosing.
Upon completion of part 1 the second part will begin. In part 2, the participants will be randomized by a statistician into 4 interventional arms, one placebo, and 3 different patch dosing frequencies. In part 2, the study will last 8 weeks with measurements at weeks 4 and 8. Part 2 will have an interim analysis at week 4, then it will proceed with only 2 study arms and make final measurements on week 8. The dosing for part 2 in the different arms of the study will be based on the part 1 results. The aim of these two studies is to establish if vitamin D supplementation via the skin improves the vitamin D status and at what dosing level/interval is required to achieve this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo patch | Placebo comparator | Dietary Supplement: Placebo transdermal patchPlacebo transdermal patch daily |
| Dose Frequency 1 | Active comparator | Dietary Supplement: Vitamin D phosphateActive transdermal patch daily (actives could be alternated with placebo in a given sequence) |
| Dose Frequency 2 | Active comparator | Dietary Supplement: Vitamin D phosphateActive transdermal patch daily (actives could be alternated with placebo in a given sequence) |
| Dose Frequency 3 | Active comparator | Dietary Supplement: Vitamin D phosphateActive transdermal patch daily (actives could be alternated with placebo in a given sequence) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adults between 18 and 65 years of age
- Suspected low vitamin D levels (defined as moderate or high risk using the Deschasaux questionnaire (10))
- Written informed consent for study participation.
- Willingness to comply with all study requirements.
- Competent use of English language.
Key exclusion criteria (6 listed)
- Patients unable to give informed consent.
- The use of vitamin D supplements 4 weeks prior to the commencement of the study (and unwilling to washout).
- Pregnancy
- Those with parathyroid, thyroid, or calcium disorders, sarcoidosis, a requirement for calcium channel blockers, Type I diabetes, and concurrent active malignancies.
- Those who have been diagnosed with vitamin D deficiency by a GP in the last 3 months using a blood test.
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 |
|---|---|---|
| Vitamin D phosphateApplication of a Vitamin D phosphate active patch | Dietary supplement | Dose Frequency 1, Dose Frequency 2, Dose Frequency 3 |
| Placebo transdermal patchApplication of a placebo transdermal patch | Dietary supplement | Placebo patch |
Primary outcome
Measurement of the % change in 25(OH)vitamin D3 concentration in human serum compared to baseline
Time frame: After 4 and 8 weeks compared to baseline
Concentration of 25(OH)vitamin in the serum (ng/ml)
3 secondary outcomes
Measurement of the % change in vitamin D binding protein concentration in human serum compared to baseline
Time frame: After 4 and 8 weeks compared to baseline
Measurement % of chemical biomarker concentrations in the human skin interstitial fluid compared to baseline
Time frame: 4 and 8 weeks compared to baseline
Measurement of the change in human nail plate characteristics measured using pixels compared to baseline
Time frame: 4 and 8 weeks compared to baseline
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 12 Aug 2025.
- Derived from this study: PubMed 42817826Kawashita M, Lim CH, Hibbard T, Andriollo P, Li Y, Lawrence KP, John E, Royall PR, Guo Q, Tasdemir D, Ayrton O, Fitzgerald O'Connor E, Benaouda F, Bashir S, Cilibrizzi A, Luebcke P, Young AR, Douiri A, O'Shaughnessy R, Carpenter G, Alhnan M, Jones SA. A UV-Free Strategy for Vitamin D Synthesis in Skin: Concept Verification and a Randomised Double-Blind Placebo-Controlled Clinical Trial of a Cholecalciferol Phosphate Patch (TransVitD). Br J Dermatol. 2026 Oct 1:ljag421. doi: 10.1093/bjd/ljag421. Online ahead of print.
- Derived from this study: PubMed 39972355Hibbard T, Andriollo P, Lim CH, Guo Q, Lawrence KP, Coker B, Malek R, Douiri A, Alhnan MA, Jones SA. A multistage double-blind placebo-controlled study to assess the safety and efficacy of transdermal vitamin D phosphate supplementation (TransVitD). Trials. 2025 Feb 19;26(1):59. doi: 10.1186/s13063-024-08711-8.
- 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.
Stuart Jones principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D phosphate in people with Vitamin D Supplementation, run by King's College London at 1 site in United Kingdom.
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 5 inclusion and 6 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 12 Aug 2025. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Measurement of the % change in 25(OH)vitamin D3 concentration in human serum compared to baseline (time frame: After 4 and 8 weeks compared to baseline). 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 NCT06098846, which also lists 2 linked publications.
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 12 Aug 2025.