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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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
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

Other trials in United Kingdom

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 groups in NCT07349290
Study groupRoleWhat they receive
Vitamin D (bio)fortified foodsExperimentalNot described
Receives: Other: Vitamin D (bio)fortified food basket
Control foodsExperimentalNot described
Receives: Other: Control food basket

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted16 Jan 2026
  2. Study start12 Feb 2026
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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)
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

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.

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