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The Efficacy of Different Vitamin D Supplementation Delivery Methods

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

vitamin D3

Pill

orange syrup

mineral oil

Penetrator

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Wolverhampton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Vitamin D3 pill

Pill placebo

Vitamin D3 oral liquid

Oral liquid placebo

Skin oil + Vitamin D3 + penetrator

Skin oil + Vitamin D3

Skin oil placebo

Arm Description

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

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

100 drops = 100,000IU in orange syrup

100 drops orange syrup

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

100,000IU + mineral oil

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

Outcomes

Primary Outcome Measures

serum 25(OH)D

Changes in serum 25(OH)D levels

Secondary Outcome Measures

Full Information

NCT ID

NCT03463642

First Posted

March 6, 2018

Last Updated

March 12, 2018

Sponsor

University of Wolverhampton

Collaborators

Royal National Orthopaedic Hospital NHS Trust, University of Worcester

1. Study Identification

Unique Protocol Identification Number

NCT03463642

Brief Title

The Efficacy of Different Vitamin D Supplementation Delivery Methods

Official Title

The Efficacy of Different Vitamin D Supplementation Delivery Methods on Serum 25(OH)D in Humans a Randomised Double-blind Placebo Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

February 2, 2017 (Actual)

Primary Completion Date

April 4, 2017 (Actual)

Study Completion Date

April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Wolverhampton

Collaborators

Royal National Orthopaedic Hospital NHS Trust, University of Worcester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3 pill

Arm Type

Experimental

Arm Description

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

Arm Title

Pill placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Vitamin D3 oral liquid

Arm Type

Experimental

Arm Description

100 drops = 100,000IU in orange syrup

Arm Title

Oral liquid placebo

Arm Type

Placebo Comparator

Arm Description

100 drops orange syrup

Arm Title

Skin oil + Vitamin D3 + penetrator

Arm Type

Experimental

Arm Description

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

Arm Title

Skin oil + Vitamin D3

Arm Type

Experimental

Arm Description

100,000IU + mineral oil

Arm Title

Skin oil placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin D3

Intervention Description

100,000IU

Intervention Type

Dietary Supplement

Intervention Name(s)

Pill

Intervention Description

Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

Intervention Type

Dietary Supplement

Intervention Name(s)

orange syrup

Intervention Description

100 drops orange syrup

Intervention Type

Other

Intervention Name(s)

mineral oil

Intervention Description

Paraffinum Liquidum,Isopropyl Palmitate,Parfum

Intervention Type

Dietary Supplement

Intervention Name(s)

Penetrator

Intervention Description

Tangerine essential oil (10ml)

Primary Outcome Measure Information:

Title

serum 25(OH)D

Description

Changes in serum 25(OH)D levels

Time Frame

4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Wolverhampton

City

Walsall

State/Province

West Midlands

ZIP/Postal Code

WS1 3BD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21118827

Citation

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.

Results Reference

result

PubMed Identifier

22426953

Citation

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.

Results Reference

result

PubMed Identifier

18991184

Citation

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.

Results Reference

result

PubMed Identifier

32703720

Citation

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.

Results Reference

derived

Learn more about this trial

The Efficacy of Different Vitamin D Supplementation Delivery Methods

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