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A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status (SCD3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608164
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : May 26, 2016
Sponsor:
Collaborators:
Northern Ireland Executive
HSC Public Health Agency
Information provided by (Responsible Party):
Dr Pamela Magee, University of Ulster

Brief Summary:

The aim of the study is to compare the effectiveness of a vitamin D3 oral spray solution with capsules at raising vitamin D status over winter.

This randomised crossover trial will aim to recruit a total of 22 healthy participants for a total of two 4-week interventions separated by a 10-week washout.


Condition or disease Intervention/treatment Phase
Vitamin D Concentration Vitamin D Status Dietary Supplement: 3000IU(75μg) vitamin D3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status: a Randomised Crossover Study
Study Start Date : August 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D oral spray solution
An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray
Dietary Supplement: 3000IU(75μg) vitamin D3
Other Name: cholecalciferol

Active Comparator: Vitamin D capsules
A capsule containing 3000IU (75micrograms) vitamin D3 per capsule
Dietary Supplement: 3000IU(75μg) vitamin D3
Other Name: cholecalciferol




Primary Outcome Measures :
  1. Total 25-hydroxyvitamin D concentration [ Time Frame: At baseline and weeks 4, 14 and 18 ]
    Total 25-hydroxyvitamin D concentration will be determined using liquid chromatography-tandem mass spectrometry in collected serum samples


Secondary Outcome Measures :
  1. Biomarkers of vitamin D metabolism [ Time Frame: At baseline and weeks 4, 14 and 18 ]
    Biomarkers of vitamin D metabolism, including parathyroid hormone and adjusted calcium will be quantified in collected serum samples by ELISA and using a clinical chemistry analyser

  2. Dietary vitamin D intake [ Time Frame: At week 18 only ]
    Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apparently healthy
  • Over the age of 18

Exclusion Criteria:

  • Those that intend to consume a supplement containing vitamin D at any point during the study
  • Those under the age of 18.
  • Individuals that are on prescribed medication that is known to affect vitamin D metabolism
  • Those following a vegan diet
  • Sun-bed users
  • Participants that are planning a sun holiday during the study

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): NCT02608164


Locations
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United Kingdom
Human Intervention Studies Unit (HISU), University of Ulster
Coleraine, Londonderry, United Kingdom, BT52 1SA
Sponsors and Collaborators
University of Ulster
Northern Ireland Executive
HSC Public Health Agency
Investigators
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Principal Investigator: Pamela J Magee, PhD University of Ulster

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Responsible Party: Dr Pamela Magee, University of Ulster
ClinicalTrials.gov Identifier: NCT02608164    
Other Study ID Numbers: REC/15/0083
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Keywords provided by Dr Pamela Magee, University of Ulster:
Healthy adults
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Pharmaceutical Solutions
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents