Vitamin D BiofortificationNCT07349290
Vitamin D (Bio)Fortified Shopping Baskets to Improve Vitamin D Status
A study testing Vitamin D (bio)fortified food basket in people with Vitamin D Biofortification and Vitamin D Fortification, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Vitamin D is essential for healthy bones, muscles, and immune function. It comes from food, supplements, and sunlight. There are two main forms; vitamin D2, found mainly in plant foods, and vitamin D3, which comes from animal foods and is more effective at increasing vitamin D levels in the body. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Biofortification, Vitamin D Fortification, Vitamin D Status
- What is being tested?
- Vitamin D (bio)fortified food basket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Households with at least one adult member (≥18 years) and at least one adolescent member (11-17 years).
- Participants willing to consume the majority of study foods provided
- Participants willing to provide a total of two blood samples (maximum 25ml at each timepoint).
Who cannot join
- Any food allergies or intolerances, including anaphylaxis allergies
- Individuals taking/unwilling to stop taking high dose vitamin D supplements (1000 IU) for a washout period (4 weeks before) and for the duration of the study period
- Other major dietary exclusions, e.g. those following vegan or vegetarian lifestyles.
- Individuals with conditions causing malabsorption, e.g. coeliac disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry
Coleraine, BT52 1SA
About this study
Official title: Vitamin D (Bio)Fortified Shopping Baskets to Improve Vitamin D Status: a Household-level RCT
Vitamin D is essential for healthy bones, muscles, and immune function. It comes from food, supplements, and sunlight. There are two main forms; vitamin D2, found mainly in plant foods, and vitamin D3, which comes from animal foods and is more effective at increasing vitamin D levels in the body. In the UK, sunlight is often too weak especially in winter for the body to make enough vitamin D, so people rely mainly on dietary sources and supplements. Despite this, many people in the UK have low vitamin D levels, and teenagers are particularly at risk due to increased needs during growth, with around one in five adolescents having low vitamin D levels. Poor intake of vitamin D-rich foods, low supplement use, and inconsistent food fortification contribute to this problem. This study aims to assess whether a family-based household diet using natural and fortified vitamin D foods during winter can improve vitamin D levels in adolescents.
Read the detailed description
Vitamin D is important for keeping bones, muscles, and the immune system healthy. There are two main types of vitamin D; vitamin D2, which mainly comes from plant-based foods, and vitamin D3, which mostly comes from animal foods and sunlight. Vitamin D3 is better at raising vitamin D levels in the body. After vitamin D is consumed or made in the skin, it is processed by the liver and kidneys into an active form that the body can use. People get vitamin D from food, supplements, and sunlight. Natural food sources include oily fish, meat, eggs, and liver. Some foods, such as breakfast cereals, spreads, and yoghurts, have vitamin D added to them (fortified foods). A small number of foods, like certain mushrooms, eggs, and bread, are also biofortified to contain higher levels of vitamin D. However, in countries like the UK, sunlight is often not strong enough especially in winter to allow the body to make enough vitamin D, so people rely more on food and supplements. Vitamin D levels are measured using a blood test. In the UK, a large proportion of the population has low vitamin D levels, with many people being either deficient or insufficient. Low vitamin D increases the risk of weak bones and bone diseases, such as rickets in children and osteoporosis in adults. Teenagers are especially at risk because their bodies need more vitamin D during periods of rapid growth. National surveys show that nearly one in five adolescents in the UK has low vitamin D levels, particularly during winter. Low intake of vitamin D-rich foods, limited supplement use, and reduced sunlight exposure all contribute to this problem. Although some foods in the UK are fortified with vitamin D, fortification is voluntary, meaning vitamin D levels vary widely between products. This makes it difficult for families to meet their vitamin D needs through diet alone. While studies have shown that vitamin D fortification can improve vitamin D levels, most research has focused on single foods rather than looking at the whole family diet. There is limited evidence on whether using a range of vitamin D-rich and fortified foods at home can help improve vitamin D levels in adolescents. This study aims to assess whether a family-based, household-level dietary intervention using natural and fortified vitamin D foods during winter can improve vitamin D status in families with adolescents.
- Being tested
- Vitamin D (bio)fortified food basket, Control food basket
- Keywords
- Vitamin D, Biofortification, Fortification, Household, Vitamin D Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (bio)fortified food basketOther
Basket of vitamin D (bio)fortified foods provided to a household for consumption
Control food basketOther
Basket of control foods provided to a household for consumption
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D (bio)fortified foods | Experimental | Not described Receives: Other: Vitamin D (bio)fortified food basket |
| Control foods | Experimental | Not described Receives: Other: Control food basket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status
Measured by LC-MS/MS for 25(OH)D concentrations (µmol/L)
Measured: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Secondary outcomes (4)
Vitamin D intake
Measured by validated Food Frequency Questionnaire, reported as average vitamin D intake µg/day.
Measured: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Acceptability of food baskets
Measured by qualitative interview to assess acceptability of food baskets provided to households
Measured: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Knowledge of vitamin D
Measured by quantitative (percentage score between 0% and 100%, higher score indicating better knowledge) and qualitative (open ended questions) questionnaire to assess knowledge of vitamin D
Measured: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Perceptions and habits of vitamin D
Measured by quantitative and qualitative (open ended questions) questionnaire to assess perception and habits of vitamin D
Measured: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start12 Feb 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D BiofortificationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised unblinded parallel household trial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Foodovation North West Regional College, Kenedy Bacon, Sofina Foods Europe, Humanativ Ltd, Agri-Food and Biosciences Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349290
- Sponsor's protocol ID
- REC/24/0076
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D (Bio)Fortified Shopping Baskets to Improve Vitamin D Status: a Household-level RCT
- ClinicalTrials.gov ID
- NCT07349290
- Acronym / sponsor ID
- REC/24/0076
- Keywords
- Vitamin D, Biofortification, Fortification, Household, Vitamin D Status
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Foodovation North West Regional College, Kenedy Bacon, Sofina Foods Europe, Humanativ Ltd, Agri-Food and Biosciences Institute
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Jan 2026 (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.
Vitamin D is essential for healthy bones, muscles, and immune function. It comes from food, supplements, and sunlight. There are two main forms; vitamin D2, found mainly in plant foods, and vitamin D3, which comes from animal foods and is more effective at increasing vitamin D levels in the body. In the UK, sunlight is often too weak especially in winter for the body to make enough vitamin D, so people rely mainly on dietary sources and supplements. Despite this, many people in the UK have low vitamin D levels, and teenagers are particularly at risk due to increased needs during growth, with around one in five adolescents having low vitamin D levels. Poor intake of vitamin D-rich foods, low supplement use, and inconsistent food fortification contribute to this problem. This study aims to assess whether a family-based household diet using natural and fortified vitamin D foods during winter can improve vitamin D levels in adolescents.
Detailed description
Vitamin D is important for keeping bones, muscles, and the immune system healthy. There are two main types of vitamin D; vitamin D2, which mainly comes from plant-based foods, and vitamin D3, which mostly comes from animal foods and sunlight. Vitamin D3 is better at raising vitamin D levels in the body. After vitamin D is consumed or made in the skin, it is processed by the liver and kidneys into an active form that the body can use. People get vitamin D from food, supplements, and sunlight. Natural food sources include oily fish, meat, eggs, and liver. Some foods, such as breakfast cereals, spreads, and yoghurts, have vitamin D added to them (fortified foods). A small number of foods, like certain mushrooms, eggs, and bread, are also biofortified to contain higher levels of vitamin D. However, in countries like the UK, sunlight is often not strong enough especially in winter to allow the body to make enough vitamin D, so people rely more on food and supplements. Vitamin D levels are measured using a blood test. In the UK, a large proportion of the population has low vitamin D levels, with many people being either deficient or insufficient. Low vitamin D increases the risk of weak bones and bone diseases, such as rickets in children and osteoporosis in adults. Teenagers are especially at risk because their bodies need more vitamin D during periods of rapid growth. National surveys show that nearly one in five adolescents in the UK has low vitamin D levels, particularly during winter. Low intake of vitamin D-rich foods, limited supplement use, and reduced sunlight exposure all contribute to this problem. Although some foods in the UK are fortified with vitamin D, fortification is voluntary, meaning vitamin D levels vary widely between products. This makes it difficult for families to meet their vitamin D needs through diet alone. While studies have shown that vitamin D fortification can improve vitamin D levels, most research has focused on single foods rather than looking at the whole family diet. There is limited evidence on whether using a range of vitamin D-rich and fortified foods at home can help improve vitamin D levels in adolescents. This study aims to assess whether a family-based, household-level dietary intervention using natural and fortified vitamin D foods during winter can improve vitamin D status in families with adolescents.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised unblinded parallel household trial
| Arm | Type | Receives |
|---|---|---|
| Vitamin D (bio)fortified foods | Experimental | Other: Vitamin D (bio)fortified food basket |
| Control foods | Experimental | Other: Control food basket |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Households with at least one adult member (≥18 years) and at least one adolescent member (11-17 years).
- Participants willing to consume the majority of study foods provided
- Participants willing to provide a total of two blood samples (maximum 25ml at each timepoint).
Key exclusion criteria (4 listed)
- Any food allergies or intolerances, including anaphylaxis allergies
- Individuals taking/unwilling to stop taking high dose vitamin D supplements (1000 IU) for a washout period (4 weeks before) and for the duration of the study period
- Other major dietary exclusions, e.g. those following vegan or vegetarian lifestyles.
- Individuals with conditions causing malabsorption, e.g. coeliac disease
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 (bio)fortified food basketBasket of vitamin D (bio)fortified foods provided to a household for consumption | Other | Vitamin D (bio)fortified foods |
| Control food basketBasket of control foods provided to a household for consumption | Other | Control foods |
Primary outcome
Vitamin D status
Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Measured by LC-MS/MS for 25(OH)D concentrations (µmol/L)
4 secondary outcomes
Vitamin D intake
Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Acceptability of food baskets
Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Knowledge of vitamin D
Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Perceptions and habits of vitamin D
Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Vitamin D Biofortification
Enrolling by invitation
Investigating the Impact of Vitamin D Biofortified Tomatoes on Serum Levels of 25(OH)D
Vitamin D Insufficiency
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.
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 (bio)fortified food basket in people with Vitamin D Biofortification and Vitamin D Fortification, 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 4 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: enrolling by invitation, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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: From enrolment to the end of treatment at 4 weeks, comparison between treatments). 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 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.