The Efficacy of Different Vitamin D Supplementation Delivery Methods

NCT ID: NCT03463642

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2017-04-04

Brief Summary

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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

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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

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vitamin D3 pill

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

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

100,000IU

Pill

Intervention Type DIETARY_SUPPLEMENT

Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

Pill placebo

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

Group Type PLACEBO_COMPARATOR

Pill

Intervention Type DIETARY_SUPPLEMENT

Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

Vitamin D3 oral liquid

100 drops = 100,000IU in orange syrup

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

100,000IU

orange syrup

Intervention Type DIETARY_SUPPLEMENT

100 drops orange syrup

Oral liquid placebo

100 drops orange syrup

Group Type PLACEBO_COMPARATOR

orange syrup

Intervention Type DIETARY_SUPPLEMENT

100 drops orange syrup

Skin oil + Vitamin D3 + penetrator

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

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

100,000IU

mineral oil

Intervention Type OTHER

Paraffinum Liquidum,Isopropyl Palmitate,Parfum

Penetrator

Intervention Type DIETARY_SUPPLEMENT

Tangerine essential oil (10ml)

Skin oil + Vitamin D3

100,000IU + mineral oil

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

100,000IU

mineral oil

Intervention Type OTHER

Paraffinum Liquidum,Isopropyl Palmitate,Parfum

Skin oil placebo

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

Group Type PLACEBO_COMPARATOR

mineral oil

Intervention Type OTHER

Paraffinum Liquidum,Isopropyl Palmitate,Parfum

Interventions

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vitamin D3

100,000IU

Intervention Type DIETARY_SUPPLEMENT

Pill

Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

Intervention Type DIETARY_SUPPLEMENT

orange syrup

100 drops orange syrup

Intervention Type DIETARY_SUPPLEMENT

mineral oil

Paraffinum Liquidum,Isopropyl Palmitate,Parfum

Intervention Type OTHER

Penetrator

Tangerine essential oil (10ml)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royal National Orthopaedic Hospital NHS Trust

OTHER

Sponsor Role collaborator

University of Worcester

OTHER

Sponsor Role collaborator

University of Wolverhampton

OTHER

Sponsor Role lead

Responsible Party

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Matthew Wyon

Professor Matthew Wyon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Wolverhampton

Walsall, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 21118827 (View on PubMed)

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.

Reference Type RESULT
PMID: 22426953 (View on PubMed)

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.

Reference Type RESULT
PMID: 18991184 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32703720 (View on PubMed)

Other Identifiers

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UoW116976

Identifier Type: -

Identifier Source: org_study_id

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