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The Efficacy of Different Vitamin D Supplementation Delivery Methods

The Efficacy of Different Vitamin D Supplementation Delivery Methods on Serum 25(OH)D in Humans a Randomised Double-blind Placebo Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03463642
Enrollment
62
Registered
2018-03-13
Start date
2017-02-02
Completion date
2017-04-04
Last updated
2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Brief summary

To test the efficacy of different vitamin D delivery methods on serum 25(OH)D. Participants randomly assigned to one of seven groups - three placebo groups and 4 active supplement groups receiving 100,000IU vitamin D3

Detailed description

Various delivery methods of vitamin D supplementation are available to consumers but there have been no studies providing evidence of whether one delivery method is superior to others. The researchers wanted to compare the delivery of 100,000IU vitamin D3 by three methods on serum 25(OH)D levels. Two methods of oral supplementation (pill \[prolonged release\] and liquid \[immediate release\]), and delivery through the skin (with and without a penetrator enhancer. Placebo groups were pill, oral liquid and skin applied oil

Interventions

DIETARY_SUPPLEMENTvitamin D3

100,000IU

DIETARY_SUPPLEMENTPill

Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

DIETARY_SUPPLEMENTorange syrup

100 drops orange syrup

Paraffinum Liquidum,Isopropyl Palmitate,Parfum

DIETARY_SUPPLEMENTPenetrator

Tangerine essential oil (10ml)

Sponsors

Royal National Orthopaedic Hospital NHS Trust
CollaboratorOTHER
University of Worcester
CollaboratorOTHER
University of Wolverhampton
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy, female

Exclusion criteria

* any participant that was taking vitamin supplementation, had a skin condition that would prevent them from applying oil to their skin or were taking, or had been taking in the past 6-months, oestrogen based contraception

Design outcomes

Primary

MeasureTime frameDescription
serum 25(OH)D4 weeksChanges in serum 25(OH)D levels

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026