The Efficacy of Different Vitamin D Supplementation Delivery Methods

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: vitamin D3; Dietary Supplement: orange syrup; Dietary Supplement: Pill; Other: mineral oil; Dietary Supplement: Penetrator

• Registration Number: NCT03463642
• Lead Sponsor: University of Wolverhampton

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

Study Timeline

• Study Start: 2017-02-02
• Primary Completion: 2017-04-04
• Study Completion: 2017-04-04
• Status Verified: 2018-03
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-06
• Last Update Submitted: 2018-03-12
• Study First Posted: 2018-03-13
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin oil + Vitamin D3 + penetrator	vitamin D3	100,000IU + mineral oil+ Tangerine essential oil (10ml)
Skin oil + Vitamin D3	vitamin D3	100,000IU + mineral oil
Vitamin D3 pill	Pill	100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
Skin oil + Vitamin D3 + penetrator	mineral oil	100,000IU + mineral oil+ Tangerine essential oil (10ml)
Vitamin D3 oral liquid	vitamin D3	100 drops = 100,000IU in orange syrup
Oral liquid placebo	orange syrup	100 drops orange syrup
Skin oil placebo	mineral oil	Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample
Vitamin D3 pill	vitamin D3	100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
Pill placebo	Pill	100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
Vitamin D3 oral liquid	orange syrup	100 drops = 100,000IU in orange syrup
Skin oil + Vitamin D3 + penetrator	Penetrator	100,000IU + mineral oil+ Tangerine essential oil (10ml)
Skin oil + Vitamin D3	mineral oil	100,000IU + mineral oil

Primary Outcome Measures

Name	Time	Method
serum 25(OH)D	4 weeks	Changes in serum 25(OH)D levels

Trial Locations

Locations (1)

University of Wolverhampton; 🇬🇧 Walsall, West Midlands, United Kingdom