NCT03463642

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

March 6, 2018

Last Update Submit

March 12, 2018

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • serum 25(OH)D

    Changes in serum 25(OH)D levels

    4 weeks

Study Arms (7)

Vitamin D3 pill

EXPERIMENTAL

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

Dietary Supplement: vitamin D3Dietary Supplement: Pill

Pill placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Pill

Vitamin D3 oral liquid

EXPERIMENTAL

100 drops = 100,000IU in orange syrup

Dietary Supplement: vitamin D3Dietary Supplement: orange syrup

Oral liquid placebo

PLACEBO COMPARATOR

100 drops orange syrup

Dietary Supplement: orange syrup

Skin oil + Vitamin D3 + penetrator

EXPERIMENTAL

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

Dietary Supplement: vitamin D3Other: mineral oilDietary Supplement: Penetrator

Skin oil + Vitamin D3

EXPERIMENTAL

100,000IU + mineral oil

Dietary Supplement: vitamin D3Other: mineral oil

Skin oil placebo

PLACEBO COMPARATOR

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

Other: mineral oil

Interventions

vitamin D3DIETARY_SUPPLEMENT

100,000IU

Skin oil + Vitamin D3Skin oil + Vitamin D3 + penetratorVitamin D3 oral liquidVitamin D3 pill
PillDIETARY_SUPPLEMENT

Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

Pill placeboVitamin D3 pill
orange syrupDIETARY_SUPPLEMENT

100 drops orange syrup

Oral liquid placeboVitamin D3 oral liquid
mineral oilOTHER

Paraffinum Liquidum,Isopropyl Palmitate,Parfum

Skin oil + Vitamin D3Skin oil + Vitamin D3 + penetratorSkin oil placebo
PenetratorDIETARY_SUPPLEMENT

Tangerine essential oil (10ml)

Skin oil + Vitamin D3 + penetrator

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wolverhampton

Walsall, West Midlands, WS1 3BD, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 21118827RESULT

  • 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.

    PMID: 22426953RESULT

  • 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.

    PMID: 18991184RESULT

  • 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.

    PMID: 32703720DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolMineral Oil

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsPetrolatumHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Matthew Wyon

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 13, 2018

Study Start

February 2, 2017

Primary Completion

April 4, 2017

Study Completion

April 4, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)