The Efficacy of Different Vitamin D Supplementation Delivery Methods

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

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: vitamin D3; Dietary supplement: Pill; Dietary supplement: orange syrup; Other: mineral oil; Dietary supplement: Penetrator

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Walsall, West Midlands, United Kingdom, WS1 3BD
      • University of Wolverhampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D3 pill; 100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate	Dietary supplement: vitamin D3; 100,000IU; Dietary supplement: Pill; Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
Placebo Comparator: Pill placebo; 100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate	Dietary supplement: Pill; Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
Experimental: Vitamin D3 oral liquid; 100 drops = 100,000IU in orange syrup	Dietary supplement: vitamin D3; 100,000IU; Dietary supplement: orange syrup; 100 drops orange syrup
Placebo Comparator: Oral liquid placebo; 100 drops orange syrup	Dietary supplement: orange syrup; 100 drops orange syrup
Experimental: Skin oil + Vitamin D3 + penetrator; 100,000IU + mineral oil+ Tangerine essential oil (10ml)	Dietary supplement: vitamin D3; 100,000IU; Other: mineral oil; Paraffinum Liquidum,Isopropyl Palmitate,Parfum; Dietary supplement: Penetrator; Tangerine essential oil (10ml)
Experimental: Skin oil + Vitamin D3; 100,000IU + mineral oil	Dietary supplement: vitamin D3; 100,000IU; Other: mineral oil; Paraffinum Liquidum,Isopropyl Palmitate,Parfum
Placebo Comparator: Skin oil placebo; Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample	Other: mineral oil; Paraffinum Liquidum,Isopropyl Palmitate,Parfum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum 25(OH)D	Changes in serum 25(OH)D levels	4 weeks

Collaborators and Investigators

• Sponsor: University of Wolverhampton
• Collaborators: Royal National Orthopaedic Hospital NHS Trust; University of Worcester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): April 4, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Dermatologic Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Emollients; Vitamin D; Cholecalciferol; Mineral Oil
• Other Study ID Numbers: UoW116976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No