NCT06098846

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

August 12, 2025

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

October 5, 2023

Last Update Submit

August 7, 2025

Conditions

Vitamin D Supplementation

Keywords

vitamin Dsupplementationtransdermal patch

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    After 4 and 8 weeks compared to baseline

  • Measurement % of chemical biomarker concentrations in the human skin interstitial fluid compared to baseline

    4 and 8 weeks compared to baseline

  • Measurement of the change in human nail plate characteristics measured using pixels compared to baseline

    4 and 8 weeks compared to baseline

Study Arms (4)

Placebo patch

PLACEBO COMPARATOR

Placebo transdermal patch daily

Dietary Supplement: Placebo transdermal patch

Dose Frequency 1

ACTIVE COMPARATOR

Active transdermal patch daily (actives could be alternated with placebo in a given sequence)

Dietary Supplement: Vitamin D phosphate

Dose Frequency 2

ACTIVE COMPARATOR

Active transdermal patch daily (actives could be alternated with placebo in a given sequence)

Dietary Supplement: Vitamin D phosphate

Dose Frequency 3

ACTIVE COMPARATOR

Active transdermal patch daily (actives could be alternated with placebo in a given sequence)

Dietary Supplement: Vitamin D phosphate

Interventions

Vitamin D phosphateDIETARY_SUPPLEMENT

Application of a Vitamin D phosphate active patch

Dose Frequency 1Dose Frequency 2Dose Frequency 3
Placebo transdermal patchDIETARY_SUPPLEMENT

Application of a placebo transdermal patch

Placebo patch

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Pharmaceutical Science, King's College London

London, London, SE19NH, United Kingdom

Location

Related Publications (1)

  • Hibbard 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.

    PMID: 39972355DERIVED

Study Officials

  • Stuart Jones

    King's College London

    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

October 5, 2023

First Posted

October 25, 2023

Study Start

October 23, 2023

Primary Completion

September 10, 2024

Study Completion

September 10, 2024

Last Updated

August 12, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)