The Efficacy of Different Vitamin D Supplementation Delivery Methods
NCT ID: NCT03463642
Last Updated: 2018-03-14
Study Results
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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COMPLETED
NA
62 participants
INTERVENTIONAL
2017-02-02
2017-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vitamin D3 pill
100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
vitamin D3
100,000IU
Pill
Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
Pill placebo
100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
Pill
Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
Vitamin D3 oral liquid
100 drops = 100,000IU in orange syrup
vitamin D3
100,000IU
orange syrup
100 drops orange syrup
Oral liquid placebo
100 drops orange syrup
orange syrup
100 drops orange syrup
Skin oil + Vitamin D3 + penetrator
100,000IU + mineral oil+ Tangerine essential oil (10ml)
vitamin D3
100,000IU
mineral oil
Paraffinum Liquidum,Isopropyl Palmitate,Parfum
Penetrator
Tangerine essential oil (10ml)
Skin oil + Vitamin D3
100,000IU + mineral oil
vitamin D3
100,000IU
mineral oil
Paraffinum Liquidum,Isopropyl Palmitate,Parfum
Skin oil placebo
Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample
mineral oil
Paraffinum Liquidum,Isopropyl Palmitate,Parfum
Interventions
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vitamin D3
100,000IU
Pill
Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
orange syrup
100 drops orange syrup
mineral oil
Paraffinum Liquidum,Isopropyl Palmitate,Parfum
Penetrator
Tangerine essential oil (10ml)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
Yes
Sponsors
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Royal National Orthopaedic Hospital NHS Trust
OTHER
University of Worcester
OTHER
University of Wolverhampton
OTHER
Responsible Party
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Matthew Wyon
Professor Matthew Wyon
Locations
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University of Wolverhampton
Walsall, West Midlands, United Kingdom
Countries
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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.
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.
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.
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.
Other Identifiers
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UoW116976
Identifier Type: -
Identifier Source: org_study_id
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