The Efficacy of Different Vitamin D Supplementation Delivery Methods

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463642
• Other study ID #: UoW116976
• Status: Completed
• Phase: N/A
• First received: March 6, 2018
• Last updated: March 12, 2018
• Start date: February 2, 2017
• Est. completion date: April 4, 2017

Study information

• Verified date: March 2018
• Source: University of Wolverhampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• vitamin D3
100,000IU
• Pill
Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
• orange syrup
100 drops orange syrup

Other:
• mineral oil
Paraffinum Liquidum,Isopropyl Palmitate,Parfum

Dietary Supplement:
• Penetrator
Tangerine essential oil (10ml)

Locations

Country	Name	City	State
United Kingdom	University of Wolverhampton	Walsall	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
University of Wolverhampton	Royal National Orthopaedic Hospital NHS Trust, University of Worcester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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 Med — View 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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25(OH)D	Changes in serum 25(OH)D levels	4 weeks