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NCT Number: NCT07349290

Vitamin D (Bio)Fortified Shopping Baskets to Improve Vitamin D Status

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.

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry

Coleraine, BT52 1SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Vitamin D (bio)fortified food basket

Other

Basket of vitamin D (bio)fortified foods provided to a household for consumption

Control food basket

Other

Basket of control foods provided to a household for consumption

Primary outcomes

  1. 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)

Secondary outcomes

  1. Vitamin D intake

    Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments

    Measured by validated Food Frequency Questionnaire, reported as average vitamin D intake µg/day.

  2. Acceptability of food baskets

    Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments

    Measured by qualitative interview to assess acceptability of food baskets provided to households

  3. Knowledge of vitamin D

    Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments

    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

  4. Perceptions and habits of vitamin D

    Time frame: From enrolment to the end of treatment at 4 weeks, comparison between treatments

    Measured by quantitative and qualitative (open ended questions) questionnaire to assess perception and habits of vitamin D

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Agri-Food and Biosciences Institute
  • Foodovation North West Regional College
  • Humanativ Ltd
  • Kenedy Bacon
  • Sofina Foods Europe

Registry information

Official study title

Vitamin D (Bio)Fortified Shopping Baskets to Improve Vitamin D Status: a Household-level RCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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