ClinicalTrials.gg
CompletedNCT03463642Updated Mar 14, 2018

The Efficacy of Different Vitamin D Supplementation Delivery Methods

An interventional study of vitamin D3 and Pill in Vitamin D Deficiency, sponsored by University of Wolverhampton. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by University of Wolverhampton · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Feb 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 228 studies testing cholecalciferol in Vitamin D Deficiency — 9 open to participants now, 16 under way, 2 of them phase 3. Cholecalciferol · Vitamin D Deficiency.

Enrollment
125th of 228
62 · median 72
Started
2017
with 9 others
No phase
113 of 228
6 open now
Registered
164th of 228
by date

Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, this one is the 125th largest by enrollment, is one of 10 that started in 2017, is one of 113 with no phase, and was the 164th registered.

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

Browse Vitamin D Deficiency studies →

Open to participants now

9 of the 228 studies testing cholecalciferol in Vitamin D Deficiency are open now, in 7 countries. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 9 open studies →

About cholecalciferol

Cholecalciferol: first FDA approval 2000 (INFUVITE ADULT), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 45 Years · female · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 228 studies testing cholecalciferol in Vitamin D Deficiency, or all of them as a file.
02

Study 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

Read the 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

03

Conditions studied

  • Vitamin D Deficiency

Browse trials for

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy, female

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Vitamin D3 pill

    100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

    Dietary Supplement: vitamin D3 · Dietary Supplement: Pill

  • Placebo comparator
    Pill placebo

    100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

    Dietary Supplement: Pill

  • Experimental
    Vitamin D3 oral liquid

    100 drops = 100,000IU in orange syrup

    Dietary Supplement: vitamin D3 · Dietary Supplement: orange syrup

  • Placebo comparator
    Oral liquid placebo

    100 drops orange syrup

    Dietary Supplement: orange syrup

  • Experimental
    Skin oil + Vitamin D3 + penetrator

    100,000IU + mineral oil+ Tangerine essential oil (10ml)

    Dietary Supplement: vitamin D3 · Other: mineral oil · Dietary Supplement: Penetrator

  • Experimental
    Skin oil + Vitamin D3

    100,000IU + mineral oil

    Dietary Supplement: vitamin D3 · Other: mineral oil

  • Placebo comparator
    Skin oil placebo

    Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample

    Other: mineral oil

Interventions

  • Dietary supplementvitamin D3

    100,000IU

  • Dietary supplementPill

    Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

  • Dietary supplementorange syrup

    100 drops orange syrup

  • Othermineral oil

    Paraffinum Liquidum,Isopropyl Palmitate,Parfum

  • Dietary supplementPenetrator

    Tangerine essential oil (10ml)

06

What researchers measure

Primary outcomes

  1. serum 25(OH)D

    Changes in serum 25(OH)D levels

    Time frame: 4 weeks

07

Study locations

1 site
  • University of Wolverhampton
    Walsall, West Midlands WS1 3BD, United Kingdom
08

References and documents

Publications

  • Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29. PubMed 21118827 ↗
  • Stoll D, Dudler J, Lamy O, Hans D, Krieg MA, Aubry-Rozier B. Can one or two high doses of oral vitamin D3 correct insufficiency in a non-supplemented rheumatologic population? Osteoporos Int. 2013 Feb;24(2):495-500. doi: 10.1007/s00198-012-1962-5. Epub 2012 Mar 17. PubMed 22426953 ↗
  • Leventis P, Kiely PD. The tolerability and biochemical effects of high-dose bolus vitamin D2 and D3 supplementation in patients with vitamin D insufficiency. Scand J Rheumatol. 2009 Mar-Apr;38(2):149-53. doi: 10.1080/03009740802419081. PubMed 18991184 ↗
  • Wyon MA, Wolman R, Martin C, Galloway S. The efficacy of different vitamin D supplementation delivery methods on serum 25(OH)D: A randomised double-blind placebo trial. Clin Nutr. 2021 Feb;40(2):388-393. doi: 10.1016/j.clnu.2020.05.040. Epub 2020 Jun 6. PubMed 32703720 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Apr 2017, 2 months.

Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's 2 months is below that.

Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2018
First posted
Mar 13, 2018
StartActual
Feb 2, 2017
Primary completionActual
Apr 4, 2017
CompletionActual
Apr 4, 2017
Last update
Mar 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03463642
Lead sponsor
University of Wolverhampton
Collaborators
Royal National Orthopaedic Hospital NHS Trust, University of Worcester
Responsible party
Matthew Wyon (Professor Matthew Wyon, University of Wolverhampton) — Principal investigator
First posted
Mar 13, 2018
Start date
Feb 2, 2017
Primary completion
Apr 4, 2017
Completion
Apr 4, 2017
Last update
Mar 14, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cholecalciferol

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