Vitamin D DeficiencyNutriPlusNCT04156074
Innovative Food Structures to Enhance Nutrient Bioavailability
A study testing Vitamin D enriched (20 mcg/day) olive oil emulsion drink, Vitamin D enriched (20 mcg/day) coconut oil emulsion drink and Vitamin D supplement (20 mcg/day) in people with Vitamin D Deficiency and Aging Well, run by University College Dublin at 1 site in Ireland.
Trial summary
This randomized controlled trial (RCT) will compare the change in vitamin D status (25-hydroxyvitamin D nmol/L) after a 4 week intervention with 4 groups: 1. Vitamin D enriched (20ug) olive oil emulsion drink 2. Vitamin D enriched (20ug) coconut oil emulsion drink 3. Placebo emulsion drink 4. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Aging Well
- What is being tested?
- Vitamin D enriched (20 mcg/day) olive oil emulsion drink, Vitamin D enriched (20 mcg/day) coconut oil emulsion drink and Vitamin D supplement (20 mcg/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIreland
- Study dates
- 4 Nov 2019to 31 Dec 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- Pregnant/lactating
- Smokers
- Individuals who are not free-living
- An inability to read, write or understand English
- Following a strict diet for any reason, insulin dependent diabetes, coeliac etc.
- Disease that requires chronic therapeutic nutritional or medical treatment
Show all 11Show fewer
- Those with conditions that may affect kidney function
- Those with osteoporosis
- Those taking supplemental vitamin D
- Those who have been on a sun holiday in the last 2 months
- Those with a milk protein allergy or lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People
This randomized controlled trial (RCT) will compare the change in vitamin D status (25-hydroxyvitamin D nmol/L) after a 4 week intervention with 4 groups:
- Vitamin D enriched (20ug) olive oil emulsion drink
- Vitamin D enriched (20ug) coconut oil emulsion drink
- Placebo emulsion drink
- Vitamin D supplement (20ug) Participants will be randomized to 1 of 4 intervention group.
Hypothesis 1: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the placebo emulsion drink group post intervention.
Hypothesis 2: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the coconut oil emulsion drink group post intervention.
- Conditions
- Vitamin D Deficiency, Aging Well
- Being tested
- Vitamin D enriched (20 mcg/day) olive oil emulsion drink, Vitamin D enriched (20 mcg/day) coconut oil emulsion drink, Placebo coconut oil emulsion drink, Vitamin D supplement (20 mcg/day)
- Keywords
- Vitamin D, Bioavailability, Aging, Fortified foods, Vitamin D status, 25-hydroxyvitamin D
- 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 enriched (20 mcg/day) olive oil emulsion drinkDietary supplement
Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily
Vitamin D enriched (20 mcg/day) coconut oil emulsion drinkDietary supplement
Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily
Placebo coconut oil emulsion drinkDietary supplement
Placebo coconut oil emulsion drink 30 mL drink daily
Vitamin D supplement (20 mcg/day)Dietary supplement
Vitamin D supplement (20 mcg/day) Pill consumed daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D enriched (20 mcg/day) olive oil emulsion drink | Experimental | 30 mL vitamin D enriched drink consumed daily for 4 weeks Receives: Dietary Supplement: Vitamin D enriched (20 mcg/day) olive oil emulsion drink |
| Vitamin D enriched (20 mcg/day) coconut oil emulsion drink | Active comparator | 30 mL vitamin D enriched drink consumed daily for 4 weeks Receives: Dietary Supplement: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink |
| Placebo coconut oil emulsion drink | Placebo comparator | 30 mL placebo drink consumed daily for 4 weeks Receives: Dietary Supplement: Placebo coconut oil emulsion drink |
| Vitamin D supplement (20 mcg/day) | Active comparator | Vitamin D supplement consumed daily for 4 weeks Receives: Dietary Supplement: Vitamin D supplement (20 mcg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status
Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)
Measured: Baseline to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start4 Nov 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Agriculture Food and the Marine
- Responsible party
- Principal investigator, Aifric O'Sullivan, University College Dublin
- Investigators
- Aifric O'Sullivan, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156074
- Sponsor's protocol ID
- LS-19-56-McCourt-OSullivan
- Acronym
- NutriPlus
- Status last verified
- Mar 2023
- First submitted
- 5 Nov 2019
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Food Structures to Enhance the Sensory Experience, the Nutrient Profile and Nutrient Bioavailability for Older People
- ClinicalTrials.gov ID
- NCT04156074
- Acronym / sponsor ID
- NutriPlus / LS-19-56-McCourt-OSullivan
- Conditions
- Vitamin D Deficiency, Aging Well
- Keywords
- Vitamin D, Bioavailability, Aging, Fortified foods, Vitamin D status, 25-hydroxyvitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Department of Agriculture Food and the Marine
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Nov 2019 (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.
This randomized controlled trial (RCT) will compare the change in vitamin D status (25-hydroxyvitamin D nmol/L) after a 4 week intervention with 4 groups:
- Vitamin D enriched (20ug) olive oil emulsion drink
- Vitamin D enriched (20ug) coconut oil emulsion drink
- Placebo emulsion drink
- Vitamin D supplement (20ug) Participants will be randomized to 1 of 4 intervention group.
Hypothesis 1: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the placebo emulsion drink group post intervention.
Hypothesis 2: 25-hydroxyvitamin D concentrations are higher in the olive oil emulsion drink group compared to the coconut oil emulsion drink group post intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Parallel Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Vitamin D enriched (20 mcg/day) olive oil emulsion drink | Experimental | Dietary Supplement: Vitamin D enriched (20 mcg/day) olive oil emulsion drink30 mL vitamin D enriched drink consumed daily for 4 weeks |
| Vitamin D enriched (20 mcg/day) coconut oil emulsion drink | Active comparator | Dietary Supplement: Vitamin D enriched (20 mcg/day) coconut oil emulsion drink30 mL vitamin D enriched drink consumed daily for 4 weeks |
| Placebo coconut oil emulsion drink | Placebo comparator | Dietary Supplement: Placebo coconut oil emulsion drink30 mL placebo drink consumed daily for 4 weeks |
| Vitamin D supplement (20 mcg/day) | Active comparator | Dietary Supplement: Vitamin D supplement (20 mcg/day)Vitamin D supplement consumed daily for 4 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (11 listed)
- Pregnant/lactating
- Smokers
- Individuals who are not free-living
- An inability to read, write or understand English
- Following a strict diet for any reason, insulin dependent diabetes, coeliac etc.
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 enriched (20 mcg/day) olive oil emulsion drinkVitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily | Dietary supplement | Vitamin D enriched (20 mcg/day) olive oil emulsion drink |
| Vitamin D enriched (20 mcg/day) coconut oil emulsion drinkVitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily | Dietary supplement | Vitamin D enriched (20 mcg/day) coconut oil emulsion drink |
| Placebo coconut oil emulsion drinkPlacebo coconut oil emulsion drink 30 mL drink daily | Dietary supplement | Placebo coconut oil emulsion drink |
| Vitamin D supplement (20 mcg/day)Vitamin D supplement (20 mcg/day) Pill consumed daily | Dietary supplement | Vitamin D supplement (20 mcg/day) |
Primary outcome
Vitamin D status
Time frame: Baseline to 28 days
Change in vitamin D status measured as serum 25-hydroxyvitamin D (nmol/L)
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 6 Mar 2023.
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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.
Aifric O'Sullivan, PhD principal investigator
University College Dublin
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 enriched (20 mcg/day) olive oil emulsion drink, Vitamin D enriched (20 mcg/day) coconut oil emulsion drink and Vitamin D supplement (20 mcg/day) in people with Vitamin D Deficiency and Aging Well, 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 11 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 6 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
Vitamin D status (time frame: Baseline to 28 days). 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 6 Mar 2023.