25-hydroxyvitamin D Concentration (Vitamin D Status)D-LightNCT02495584
D-Light Intervention
A study testing Fortified milk (10µg vitamin D3) and 10µg vitamin D3 supplement in people with 25-hydroxyvitamin D Concentration (Vitamin D Status), run by University of Ulster at 1 site in United Kingdom.
Trial summary
Vitamin D insufficiency has become a global concern, with low vitamin D status associated with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude, increased use of sunscreen, decreased sun… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- 25-hydroxyvitamin D Concentration (Vitamin D Status)
- What is being tested?
- Fortified milk (10µg vitamin D3) and 10µg vitamin D3 supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Oct 2015
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-40 years old
- Apparently healthy
- Living on the island of Ireland
Who cannot join
- Below 20 years and aged 40 years or above
- Not living on the island of Ireland
- Pregnant or lactating women and those planning to become pregnant
- Individuals who have been taking a vitamin D or calcium containing supplement in the previous three months
- Those with food intolerances or allergies that would affect their ability to consume study milk
- Individuals following a diet which excludes milk (e.g. vegans)
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- Those with a diagnosed chronic medical condition or on prescribed medication known to effect vitamin D metabolism
- Those who are planning a sun holiday during the winter months (Oct-Mar)
- Adults with learning, or any other difficulties that would prevent them from completing the study protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit
Coleraine, BT52 1SA
About this study
Official title: D-Light Intervention: A Randomised Controlled Human Intervention Study to Assess the Impact of Vitamin D From Milk and Supplements on Functional Health Outcomes and Future Vitamin D Synthesis From UV Exposure
Vitamin D insufficiency has become a global concern, with low vitamin D status associated with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude, increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status, with lower levels noted in the winter months. Variations in vitamin D status have been known to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin D during the winter months, causing us to rely on dietary sources. The aim of this intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this intervention will affect subsequent dermal synthesis of vitamin D from UV exposure. Participants will be recruited from the local community. Blood samples will be collected from each participant at two timepoints (September/October and March/April). Pre- and post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences will be measured, in addition participants will undergo a dual energy x-ray absorptiometry (DXA) scan to assess body composition and bone mineral density. Information on general health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will be collected. Following the dietary intervention, a subset of participants will be invited to participate in a follow-up study, examining UV exposure during the summer months, when they will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2 additional blood samples.
- Being tested
- Fortified milk (10µg vitamin D3), Unfortified milk (placebo), 10µg vitamin D3 supplement, Placebo supplement
- Keywords
- Vitamin D, Fortified milk, Supplementation, UV exposure, Winter, Healthy adults, Body Composition, Muscle function, Blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified milk (10µg vitamin D3)Dietary supplement
Unfortified milk (placebo)Dietary supplement
10µg vitamin D3 supplementDietary supplement
Placebo supplementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | 500ml fortified milk (10µg vitamin D3) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks Receives: Dietary Supplement: Fortified milk (10µg vitamin D3); Dietary Supplement: 10µg vitamin D3 supplement |
| Treatment 2 | Experimental | 500ml fortified milk (10µg vitamin D3) +1 supplement capsule (placebo) daily for 24 weeks Receives: Dietary Supplement: Fortified milk (10µg vitamin D3); Dietary Supplement: Placebo supplement |
| Treatment 3 | Experimental | 500ml unfortified milk (placebo) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks Receives: Dietary Supplement: Unfortified milk (placebo); Dietary Supplement: 10µg vitamin D3 supplement |
| Treatment 4 | Placebo comparator | 500ml unfortified milk (placebo) +1 supplement capsule (placebo) daily for 24 weeks Receives: Dietary Supplement: Unfortified milk (placebo); Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D status (25-hydroxyvitamin D serum concentration)
Blood analysis
Measured: Baseline + post-intervention (24weeks)
Secondary outcomes (6)
Change in body composition
Assessed by dual energy X-ray absorptiometry (DXA)
Measured: Baseline + post-intervention (24weeks)
Change in muscle strength
Assessed by grip strength
Measured: Baseline + post-intervention (24weeks)
Change in inflammation status
Blood analysis
Measured: Baseline + post-intervention (24weeks)
Change in lipid profile
Blood analysis
Measured: Baseline + post-intervention (24weeks)
Change in glucose levels
Blood analysis
Measured: Baseline + post-intervention (24weeks)
Change in insulin concentrations
Blood analysis
Measured: Baseline + post-intervention (24weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 25-hydroxyvitamin D Concentration (Vitamin D Status)Studies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Council for Northern Ireland, Agri-Food and Biosciences Institute, Center for Nutrition and Health, RIVM (The Netherlands)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495584
- Sponsor's protocol ID
- 13/NI/0091
- Acronym
- D-Light
- Status last verified
- Jan 2016
- First submitted
- 11 May 2015
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-Light Intervention: A Randomised Controlled Human Intervention Study to Assess the Impact of Vitamin D From Milk and Supplements on Functional Health Outcomes and Future Vitamin D Synthesis From UV Exposure
- ClinicalTrials.gov ID
- NCT02495584
- Acronym / sponsor ID
- D-Light / 13/NI/0091
- Keywords
- Vitamin D, Fortified milk, Supplementation, UV exposure, Winter, Healthy adults, Body Composition, Muscle function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Dairy Council for Northern Ireland, Agri-Food and Biosciences Institute, Center for Nutrition and Health, RIVM (The Netherlands)
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Jul 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.
Vitamin D insufficiency has become a global concern, with low vitamin D status associated with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude, increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status, with lower levels noted in the winter months. Variations in vitamin D status have been known to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin D during the winter months, causing us to rely on dietary sources. The aim of this intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this intervention will affect subsequent dermal synthesis of vitamin D from UV exposure. Participants will be recruited from the local community. Blood samples will be collected from each participant at two timepoints (September/October and March/April). Pre- and post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences will be measured, in addition participants will undergo a dual energy x-ray absorptiometry (DXA) scan to assess body composition and bone mineral density. Information on general health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will be collected. Following the dietary intervention, a subset of participants will be invited to participate in a follow-up study, examining UV exposure during the summer months, when they will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2 additional blood samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Dietary Supplement: Fortified milk (10µg vitamin D3), Dietary Supplement: 10µg vitamin D3 supplement500ml fortified milk (10µg vitamin D3) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks |
| Treatment 2 | Experimental | Dietary Supplement: Fortified milk (10µg vitamin D3), Dietary Supplement: Placebo supplement500ml fortified milk (10µg vitamin D3) +1 supplement capsule (placebo) daily for 24 weeks |
| Treatment 3 | Experimental | Dietary Supplement: Unfortified milk (placebo), Dietary Supplement: 10µg vitamin D3 supplement500ml unfortified milk (placebo) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks |
| Treatment 4 | Placebo comparator | Dietary Supplement: Unfortified milk (placebo), Dietary Supplement: Placebo supplement500ml unfortified milk (placebo) +1 supplement capsule (placebo) daily for 24 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-40 years old
- Apparently healthy
- Living on the island of Ireland
Key exclusion criteria (9 listed)
- Below 20 years and aged 40 years or above
- Not living on the island of Ireland
- Pregnant or lactating women and those planning to become pregnant
- Individuals who have been taking a vitamin D or calcium containing supplement in the previous three months
- Those with food intolerances or allergies that would affect their ability to consume study milk
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 |
|---|---|---|
| Fortified milk (10µg vitamin D3) | Dietary supplement | Treatment 1, Treatment 2 |
| Unfortified milk (placebo) | Dietary supplement | Treatment 3, Treatment 4 |
| 10µg vitamin D3 supplement | Dietary supplement | Treatment 1, Treatment 3 |
| Placebo supplement | Dietary supplement | Treatment 2, Treatment 4 |
Primary outcome
Change in vitamin D status (25-hydroxyvitamin D serum concentration)
Time frame: Baseline + post-intervention (24weeks)
Blood analysis
6 secondary outcomes
Change in body composition
Time frame: Baseline + post-intervention (24weeks)
Change in muscle strength
Time frame: Baseline + post-intervention (24weeks)
Change in inflammation status
Time frame: Baseline + post-intervention (24weeks)
Change in lipid profile
Time frame: Baseline + post-intervention (24weeks)
Change in glucose levels
Time frame: Baseline + post-intervention (24weeks)
Change in insulin concentrations
Time frame: Baseline + post-intervention (24weeks)
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 15 Jan 2016.
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 Fortified milk (10µg vitamin D3) and 10µg vitamin D3 supplement in people with 25-hydroxyvitamin D Concentration (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 3 inclusion and 9 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 15 Jan 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. 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?
Change in vitamin D status (25-hydroxyvitamin D serum concentration) (time frame: Baseline + post-intervention (24weeks)). 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 15 Jan 2016.