Vitamin D DeficiencyNCT03463642
The Efficacy of Different Vitamin D Supplementation Delivery Methods
A study testing vitamin D3, Pill and orange syrup in people with Vitamin D Deficiency, run by University of Wolverhampton at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D3, Pill and orange syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2017to 4 Apr 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, female
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Wolverhampton
Walsall, West Midlands, WS1 3BD
About this study
Official title: The Efficacy of Different Vitamin D Supplementation Delivery Methods on Serum 25(OH)D in Humans a Randomised Double-blind Placebo Trial
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
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D3, Pill, orange syrup, mineral oil, Penetrator
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
100,000IU
PillDietary supplement
Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
orange syrupDietary supplement
100 drops orange syrup
mineral oilOther
Paraffinum Liquidum,Isopropyl Palmitate,Parfum
PenetratorDietary supplement
Tangerine essential oil (10ml)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 pill | Experimental | 100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate Receives: Dietary Supplement: vitamin D3; Dietary Supplement: Pill |
| Pill placebo | Placebo comparator | 100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate Receives: Dietary Supplement: Pill |
| Vitamin D3 oral liquid | Experimental | 100 drops = 100,000IU in orange syrup Receives: Dietary Supplement: vitamin D3; Dietary Supplement: orange syrup |
| Oral liquid placebo | Placebo comparator | 100 drops orange syrup Receives: Dietary Supplement: orange syrup |
| Skin oil + Vitamin D3 + penetrator | Experimental | 100,000IU + mineral oil+ Tangerine essential oil (10ml) Receives: Dietary Supplement: vitamin D3; Other: mineral oil; Dietary Supplement: Penetrator |
| Skin oil + Vitamin D3 | Experimental | 100,000IU + mineral oil Receives: Dietary Supplement: vitamin D3; Other: mineral oil |
| Skin oil placebo | Placebo comparator | Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample Receives: Other: mineral oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25(OH)D
Changes in serum 25(OH)D levels
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start2 Feb 2017
- Primary completion4 Apr 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wolverhampton
- Sponsor type
- University, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust, University of Worcester
- Responsible party
- Principal investigator, Matthew Wyon, University of Wolverhampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463642
- Sponsor's protocol ID
- UoW116976
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21118827Stoll 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 22426953Leventis 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 18991184Wyon 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Different Vitamin D Supplementation Delivery Methods on Serum 25(OH)D in Humans a Randomised Double-blind Placebo Trial
- ClinicalTrials.gov ID
- NCT03463642
- Acronym / sponsor ID
- UoW116976
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of WolverhamptonUniversity, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust, University of Worcester
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 13 Mar 2018 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 pill | Experimental | Dietary Supplement: vitamin D3, Dietary Supplement: Pill100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate |
| Pill placebo | Placebo comparator | Dietary Supplement: Pill100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate |
| Vitamin D3 oral liquid | Experimental | Dietary Supplement: vitamin D3, Dietary Supplement: orange syrup100 drops = 100,000IU in orange syrup |
| Oral liquid placebo | Placebo comparator | Dietary Supplement: orange syrup100 drops orange syrup |
| Skin oil + Vitamin D3 + penetrator | Experimental | Dietary Supplement: vitamin D3, Other: mineral oil, Dietary Supplement: Penetrator100,000IU + mineral oil+ Tangerine essential oil (10ml) |
| Skin oil + Vitamin D3 | Experimental | Dietary Supplement: vitamin D3, Other: mineral oil100,000IU + mineral oil |
| Skin oil placebo | Placebo comparator | Other: mineral oilSkin application: 100ml of mineral oil coloured with food colourant to match active oil sample |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, female
Key exclusion criteria (1 listed)
- 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
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 D3100,000IU | Dietary supplement | Skin oil + Vitamin D3, Skin oil + Vitamin D3 + penetrator, Vitamin D3 oral liquid, Vitamin D3 pill |
| PillDicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate | Dietary supplement | Pill placebo, Vitamin D3 pill |
| orange syrup100 drops orange syrup | Dietary supplement | Oral liquid placebo, Vitamin D3 oral liquid |
| mineral oilParaffinum Liquidum,Isopropyl Palmitate,Parfum | Other | Skin oil + Vitamin D3, Skin oil + Vitamin D3 + penetrator, Skin oil placebo |
| PenetratorTangerine essential oil (10ml) | Dietary supplement | Skin oil + Vitamin D3 + penetrator |
Primary outcome
serum 25(OH)D
Time frame: 4 weeks
Changes in serum 25(OH)D levels
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 14 Mar 2018.
- Results publication: PubMed 21118827Ross 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.
- Results publication: PubMed 22426953Stoll 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.
- Results publication: PubMed 18991184Leventis 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.
- Derived from this study: PubMed 32703720Wyon 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 D3, Pill and orange syrup in people with Vitamin D Deficiency, run by University of Wolverhampton 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 1 inclusion and 1 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 14 Mar 2018. 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?
serum 25(OH)D (time frame: 4 weeks). 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 NCT03463642, which also lists 4 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 14 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.