Transdermal vitamin D supplementation using a patch

Double-Blind Placebo-Controlled Human Transdermal Vitamin D Supplement Study

This study is testing a vitamin D patch to see if it can help healthy adults at risk of deficiency get enough vitamin D.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: King's College London (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT06098846 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a transdermal patch for delivering vitamin D to individuals at risk of deficiency. Healthy adults aged 18 to 65 will be recruited in central London, and their vitamin D levels will be assessed through questionnaires and blood tests. Participants will receive either the vitamin D patch or a placebo in a two-part pilot study to determine the optimal dosage and efficacy of the transdermal delivery method.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 who are suspected to have low vitamin D levels.

Not a fit: Patients with recent diagnoses of vitamin D deficiency or those with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and patient-friendly method for addressing vitamin D deficiency.

How similar studies have performed: While transdermal delivery of supplements is a novel approach, similar studies have shown promise in other areas of supplementation.

Eligibility criteria

Inclusion Criteria:

1. Healthy adults between 18 and 65 years of age
2. Suspected low vitamin D levels (defined as moderate or high risk using the Deschasaux questionnaire (10))
3. Written informed consent for study participation.
4. Willingness to comply with all study requirements.
5. Competent use of English language.

Exclusion Criteria:

1. Patients unable to give informed consent.
2. The use of vitamin D supplements 4 weeks prior to the commencement of the study (and unwilling to washout).
3. Pregnancy
4. Those with parathyroid, thyroid, or calcium disorders, sarcoidosis, a requirement for calcium channel blockers, Type I diabetes, and concurrent active malignancies.
5. Those who have been diagnosed with vitamin D deficiency by a GP in the last 3 months using a blood test.
6. 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.

Where this trial is running

London

• Institute of Pharmaceutical Science, King's College London — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Stuart Jones — King's College London
• Study coordinator: Stuart Jones, PhD

Conditions Vitamin D Supplementation; vitamin D; supplementation; transdermal patch