Vitamin D DeficiencyNCT04935034
Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
A study testing Vitamin D supplement in people with Vitamin D Deficiency, run by University College Dublin at 1 site in Ireland.
Trial summary
The proposed study will examine vitamin D bioavailability when 20µg of vitamin D is consumed in 5 different forms: i) a vitamin D enriched pre-formed mixed micelle dairy drink ii) a vitamin D enriched olive oil dairy drink iii) a vitamin D enriched fish oil dairy drink iv) a vitamin D enriched fat-free dairy drink Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jul 2018to 31 May 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women
Who cannot join
- Pregnant or lactating Smokers Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc.
- An inability to read, write or understand English Following a strict prescribed diet for any reason, insulin dependent diabetes, coeliac disease, Crohn's disease Disease or condition that requires chronic therapeutic nutritional or medical treatment.
- Those taking supplemental vitamin D Those who have been on a sun holiday in the last 2 months
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study will examine vitamin D bioavailability when 20µg of vitamin D is consumed in 5 different forms:
- a vitamin D enriched pre-formed mixed micelle dairy drink ii) a vitamin D enriched olive oil dairy drink iii) a vitamin D enriched fish oil dairy drink iv) a vitamin D enriched fat-free dairy drink
Read the detailed description
This postprandial study will recruit healthy males and females aged 18 and over. Upon completion of informed consent procedures and successful screening, the volunteers will complete 4 study visits. Participants will consume a standardised meal the evening before each test day, and will arrive in the morning to the research facility in UCD after an overnight fast of 12 hours.
On the study test days, volunteers will be given one of the following vitamin D treatments in a dairy drink, followed by a low-fat breakfast.
- mixed micelles
- olive oil
- fish oil
- fat-free
Participants will also be given a low-fat lunch 5 hours after the supplement is consumed. Volunteers will be cannulated by a trained phlebotomist on arrival, and a fasting blood sample will be taken. Following ingestion of the vitamin D supplements blood samples will be taken at 0,2,4,6, and 8 hours post ingestion. A 10mL sample will be collected at each time point. In total, 60mL of blood will be collected over 24 hours. The participant's food intake will be recorded during the visit.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D supplement
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementDietary supplement
This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D enriched mixed micelles dairy drink | Experimental | 20ug vitamin D in pre-formed mixed micelle dairy drink Receives: Dietary Supplement: Vitamin D supplement |
| Vitamin D enriched olive oil dairy drink | Active comparator | 20ug vitamin D in olive oil dairy drink Receives: Dietary Supplement: Vitamin D supplement |
| Vitamin D enriched fish oil dairy drink | Active comparator | 20ug vitamin D in fish oil dairy drink Receives: Dietary Supplement: Vitamin D supplement |
| Vitamin D enriched fat-free dairy drink | Active comparator | 20ug vitamin D in fat-free dairy drink Receives: Dietary Supplement: Vitamin D supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 25-hydroxyvitamin D (25(OH)D)
Change in 25(OH)D up to 8 hours after consuming the vitamin D enriched dairy drink
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jul 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The is a 4 arm single-blinded crossover study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aifric O'Sullivan, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935034
- Sponsor's protocol ID
- LS-20-53-OSullivan-McCourt
- Status last verified
- Sep 2024
- First submitted
- 15 Jun 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the start of the study each participant will have a study code assigned to them. All of the data from the trials will be stored using these unique study codes. A file will be set up which will be stored in a location separate to the study data. This file will contain a list which will link each participants contact details to the corresponding ID code. All stored information will be encrypted and protected by a password that only the researcher and PI will know.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
- ClinicalTrials.gov ID
- NCT04935034
- Acronym / sponsor ID
- LS-20-53-OSullivan-McCourt
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 22 Jun 2021 (actual)
- 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 proposed study will examine vitamin D bioavailability when 20µg of vitamin D is consumed in 5 different forms:
- a vitamin D enriched pre-formed mixed micelle dairy drink ii) a vitamin D enriched olive oil dairy drink iii) a vitamin D enriched fish oil dairy drink iv) a vitamin D enriched fat-free dairy drink
Detailed description
This postprandial study will recruit healthy males and females aged 18 and over. Upon completion of informed consent procedures and successful screening, the volunteers will complete 4 study visits. Participants will consume a standardised meal the evening before each test day, and will arrive in the morning to the research facility in UCD after an overnight fast of 12 hours.
On the study test days, volunteers will be given one of the following vitamin D treatments in a dairy drink, followed by a low-fat breakfast.
- mixed micelles
- olive oil
- fish oil
- fat-free
Participants will also be given a low-fat lunch 5 hours after the supplement is consumed. Volunteers will be cannulated by a trained phlebotomist on arrival, and a fasting blood sample will be taken. Following ingestion of the vitamin D supplements blood samples will be taken at 0,2,4,6, and 8 hours post ingestion. A 10mL sample will be collected at each time point. In total, 60mL of blood will be collected over 24 hours. The participant's food intake will be recorded during the visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The is a 4 arm single-blinded crossover study
| Arm | Type | Receives |
|---|---|---|
| Vitamin D enriched mixed micelles dairy drink | Experimental | Dietary Supplement: Vitamin D supplement20ug vitamin D in pre-formed mixed micelle dairy drink |
| Vitamin D enriched olive oil dairy drink | Active comparator | Dietary Supplement: Vitamin D supplement20ug vitamin D in olive oil dairy drink |
| Vitamin D enriched fish oil dairy drink | Active comparator | Dietary Supplement: Vitamin D supplement20ug vitamin D in fish oil dairy drink |
| Vitamin D enriched fat-free dairy drink | Active comparator | Dietary Supplement: Vitamin D supplement20ug vitamin D in fat-free dairy drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men and women
Key exclusion criteria (3 listed)
- Pregnant or lactating Smokers Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc.
- An inability to read, write or understand English Following a strict prescribed diet for any reason, insulin dependent diabetes, coeliac disease, Crohn's disease Disease or condition that requires chronic therapeutic nutritional or medical treatment.
- Those taking supplemental vitamin D Those who have been on a sun holiday in the last 2 months
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 |
|---|---|---|
| Vitamin D supplementThis intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations. | Dietary supplement | Vitamin D enriched fat-free dairy drink, Vitamin D enriched fish oil dairy drink, Vitamin D enriched mixed micelles dairy drink, Vitamin D enriched olive oil dairy drink |
Primary outcome
Change in 25-hydroxyvitamin D (25(OH)D)
Time frame: 8 hours
Change in 25(OH)D up to 8 hours after consuming the vitamin D enriched dairy drink
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 19 Sep 2024.
- Individual participant dataSharing planned: No. At the start of the study each participant will have a study code assigned to them. All of the data from the trials will be stored using these unique study codes. A file will be set up which will be stored in a location separate to the study data. This file will contain a list which will link each participants contact details to the corresponding ID code. All stored information will be encrypted and protected by a password that only the researcher and PI will know.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D supplement in people with Vitamin D Deficiency, run by University College Dublin at 1 site in Ireland.
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 1 inclusion and 3 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 19 Sep 2024. 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 Ireland. 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?
Change in 25-hydroxyvitamin D (25(OH)D) (time frame: 8 hours). 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 19 Sep 2024.