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OpenTrials
Completed

NCT Number: NCT03463642

The Efficacy of Different Vitamin D Supplementation Delivery Methods

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

Completed

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wolverhampton

Walsall, West Midlands, WS1 3BD, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

100,000IU

Pill

Dietary Supplement

Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate

orange syrup

Dietary Supplement

100 drops orange syrup

Mineral Oil

Other

Paraffinum Liquidum,Isopropyl Palmitate,Parfum

Penetrator

Dietary Supplement

Tangerine essential oil (10ml)

Primary outcomes

  1. serum 25(OH)D

    Time frame: 4 weeks

    Changes in serum 25(OH)D levels

Sponsors and collaborators

Lead sponsor

University of Wolverhampton

Other

Collaborators

  • Royal National Orthopaedic Hospital NHS Trust
  • University of Worcester

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2018
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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