Vitamin D ConcentrationSCD3NCT02608164
A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status
A study testing 3000IU(75μg) vitamin D3 in people with Vitamin D Concentration and Vitamin D Status, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Concentration, Vitamin D Status
- What is being tested?
- 3000IU(75μg) vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy
- Over the age of 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit (HISU), University of Ulster
Coleraine, Londonderry, BT52 1SA
About this study
Official title: A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status: a Randomised Crossover Study
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.
- Conditions
- Vitamin D Concentration, Vitamin D Status
- Being tested
- 3000IU(75μg) vitamin D3
- Keywords
- Healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3000IU(75μg) vitamin D3Dietary supplement
Also called cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D oral spray solution | Active comparator | An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray Receives: Dietary Supplement: 3000IU(75μg) vitamin D3 |
| Vitamin D capsules | Active comparator | A capsule containing 3000IU (75micrograms) vitamin D3 per capsule Receives: Dietary Supplement: 3000IU(75μg) vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 25-hydroxyvitamin D concentration
Total 25-hydroxyvitamin D concentration will be determined using liquid chromatography-tandem mass spectrometry in collected serum samples
Measured: At baseline and weeks 4, 14 and 18
Secondary outcomes (2)
Biomarkers of vitamin D metabolism
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
Measured: At baseline and weeks 4, 14 and 18
Dietary vitamin D intake
Dietary vitamin D and calcium intake will be estimated using a validated food frequency questionnaire
Measured: At week 18 only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D ConcentrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ireland Executive, HSC Public Health Agency
- Responsible party
- Principal investigator, Dr Pamela Magee, University of Ulster
- Investigators
- Pamela J Magee, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608164
- Sponsor's protocol ID
- REC/15/0083
- Acronym
- SCD3
- Status last verified
- May 2016
- First submitted
- 16 Nov 2015
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status: a Randomised Crossover Study
- ClinicalTrials.gov ID
- NCT02608164
- Acronym / sponsor ID
- SCD3 / REC/15/0083
- Conditions
- Vitamin D Concentration, Vitamin D Status
- Keywords
- Healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Northern Ireland Executive, HSC Public Health Agency
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D oral spray solution | Active comparator | Dietary Supplement: 3000IU(75μg) vitamin D3An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray |
| Vitamin D capsules | Active comparator | Dietary Supplement: 3000IU(75μg) vitamin D3A capsule containing 3000IU (75micrograms) vitamin D3 per capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Apparently healthy
- Over the age of 18
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3000IU(75μg) vitamin D3Also: cholecalciferol | Dietary supplement | Vitamin D capsules, Vitamin D oral spray solution |
Primary outcome
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
2 secondary outcomes
Biomarkers of vitamin D metabolism
Time frame: At baseline and weeks 4, 14 and 18
Dietary vitamin D intake
Time frame: At week 18 only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
Related trials for Vitamin D Concentration
RecruitingObservational study
Vitamin D Status and Clinical Outcomes in Locally Advanced Cervical Cancer
Locally Advanced Cervical Cancer, Vitamin D Concentration
Recruiting
Phosphorus-31 Spectroscopy in Phosphate Diabetes
Phosphate Diabetes, X-linked Hypophosphatemia
Recruiting
Effects of High-Dose Vitamin D on Hormones, Neuromuscular Function, Cognition, and Body Composition in Athletes
Vitamin D 25-Hydroxylase Deficiency, Vitamin D Deficiency/Insufficiency
RecruitingObservational study
Vitamin B12, Folic Acid and Vitamin D Status in Women of Reproductive Age
Vitamin D, Vitamin B 12 and Folic Acid Concentrations, Micronutrient Status in Women of Reproductive Age
Not yet recruitingObservational study
Vitamin D Satus in Adults With Newly Diagnosed ITP
Vitamin D Concentration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela J Magee, PhD principal investigator
University of Ulster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3000IU(75μg) vitamin D3 in people with Vitamin D Concentration and Vitamin D Status, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 25-hydroxyvitamin D concentration (time frame: At baseline and weeks 4, 14 and 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.