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Trial record 36 of 40 for:    Citrus reticulata

The Efficacy of Different Vitamin D Supplementation Delivery Methods

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ClinicalTrials.gov Identifier: NCT03463642
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Royal National Orthopaedic Hospital NHS Trust
University of Worcester
Information provided by (Responsible Party):
Matthew Wyon, 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

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: vitamin D3 Dietary Supplement: Pill Dietary Supplement: orange syrup Other: mineral oil Dietary Supplement: Penetrator Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Different Vitamin D Supplementation Delivery Methods on Serum 25(OH)D in Humans a Randomised Double-blind Placebo Trial
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : April 4, 2017
Actual Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. serum 25(OH)D [ Time Frame: 4 weeks ]
    Changes in serum 25(OH)D levels



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463642


Locations
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United Kingdom
University of Wolverhampton
Walsall, West Midlands, United Kingdom, WS1 3BD
Sponsors and Collaborators
University of Wolverhampton
Royal National Orthopaedic Hospital NHS Trust
University of Worcester

Publications of Results:
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Responsible Party: Matthew Wyon, Professor Matthew Wyon, University of Wolverhampton
ClinicalTrials.gov Identifier: NCT03463642     History of Changes
Other Study ID Numbers: UoW116976
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Mineral Oil
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Emollients
Dermatologic Agents