Vitamin D InsufficiencyViTaL-DNCT07142759
Investigating the Impact of Vitamin D Biofortified Tomatoes on Serum Levels of 25(OH)D
A study testing Precision Bred Provitamin D-rich Tomato Soup, Precision Bred Vitamin D-rich Tomato Soup and Wild-type (store-bought) Tomato Soup in people with Vitamin D Insufficiency, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
In the UK, vitamin D deficiency occurs frequently especially during the winter months. Vitamin D biofortified tomatoes have been developed using precision breeding technique by researchers at John Innes Centre. Biofortification uses crop breeding to increase the nutritional value of crops. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Insufficiency
- What is being tested?
- Precision Bred Provitamin D-rich Tomato Soup, Precision Bred Vitamin D-rich Tomato Soup and Wild-type (store-bought) Tomato Soup
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2025to 31 Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing to eat a tomato soup daily for 21 days.
- Have access to a smartphone or tablet device and internet access.
- Be at least 18 years old
- Be able to understand the study and provide informed consent
- Have serum 25-hydroxyvitamin D (25[OH]D) levels between 25-40 nmol/L
- Body Mass Index 18.5 to 35 kg/m2
- Live within 40 miles of the Quadram Institute.
Who cannot join
- Have a known allergy or intolerance to tomatoes or to any of the soup components (tomatoes, milk, wheat, lanolin are the major allergens, but a detailed list is in Annex 16) of the test soups.
- Currently undergoing treatment or on medications for hypo/hypercalcaemia, hypo/hyperparathyroidism, kidney stones, or bone diseases.
- Have anaemia, immunocompromised or viral infections that may compromise immunity. This will be assessed on a case-by-case basis by QI medical advisor.
- Have any acute or chronic illnesses that affects the outcome of the study such as a gastrointestinal disorder. This will be assessed on a case-by-case basis by Quadram Institute medical advisor.
- Have just started taking or changed dose of vitamin D supplement in the month prior to the start of the intervention or at any point during the intervention, or are regularly taking more than 400 International Units (IU) of vitamin D.
- Are on a routine regimen of vitamin D supplementation over 400 IU who have begun supplementation or had changes in their dose a month prior or have changes during the course of the study.
Show all 15Show fewer
- Are on any medication regimen that may alter vitamin D absorption they are as follow but not limited to; bile acid sequestrants, hormone replacement therapy, thiazides, calcium channel blockers, isoniazid, anti-seizure medications, and antacids.
- Any dietary restriction that prevents the consumption of the study soups or follow a diet programme which requires fasting for multiple days (soups are not suitable for vegans).
- Have abnormally low or high blood pressure (i.e. ≤90/60, ≥160/100).
- Plan to become pregnant during the study duration, pregnant or breastfeeding.
- Are currently taking part in an intervention study.
- Are a registered blood donor and have donated a large quantity of blood within the last 6 weeks. Registered blood donors should abstain from blood donations for the duration of the study.
- Are unable to give written or verbal informed consent
- Unable to provide your GP contact details.
- Fall under the line management structure or live in the same household with any of the research team, or the QIB Human Studies Team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating the Impact of Vitamin D Biofortified Tomatoes on Serum Levels of 25(OH)D - a Two Phase, a Randomized Double-blind Placebo-controlled Parallel Arm Trial (RCT)
In the UK, vitamin D deficiency occurs frequently especially during the winter months. Vitamin D biofortified tomatoes have been developed using precision breeding technique by researchers at John Innes Centre. Biofortification uses crop breeding to increase the nutritional value of crops. The goal of the ViTaL-D study is to examine whether the vitamin D biofortified tomatoes when eaten as a soup can increase blood levels of vitamin D in men and women with vitamin D deficiency. Additionally, researchers will learn if the tomato soups are feasible and safe to eat everyday. The main questions the study aims to answer are:
- Does vitamin D biofortified tomatoes increase vitamin D levels in men and women with low blood levels of vitamin D?
- Is consuming vitamin D biofortified tomatoes safe and easy to eat everyday as a soup?
Read more
Researchers will compare how four types of tomato soup increase blood vitamin D levels. The four types of soup are:
- Soup with vitamin D biofortified tomatoes
- Soup with provitamin D biofortified tomatoes
- Soup with store-bought tomatoes not containing vitamin D
- Soup with store-bought tomatoes with added vitamin D
Participants will:
- Eat one of the four types of tomato soup every day for 21 days.
- Visit the clinic once every 7 days after a 12 hour fast for body measurements, tests, and surveys.
- Keep a daily diary when soups are eaten and when time is spent outside.
Read the detailed description
The ViTaL-D study is a 21-day randomized, double-blind, placebo-controlled four-arm parallel pilot study conducted at the NIHR (National Institute for Health and Care Research) Norfolk Clinical Research Facility (CRF) in the Quadram Institute in Norwich. Researchers are seeking adult (at least 18 years and older) men and women who have serum 25-hydroxyvitamin D (25[OH]D) levels between 25-40 nmol/L to determine whether soups made with precision bred, biofortified vitamin D tomatoes will increase vitamin D levels. There are a total of 6 study visits (1 consent visit, 1 screening visit, and 4 short visits). At these visits, anthropometric measurements and vital signs will be collected. Participants will be asked to complete questionnaires (food frequency, international physical activity, and sensory evaluation). They will record their daily consumption of soup as well as their daily sun exposure and wear a UV tracker when they are outdoors.
Researchers will measure fasting blood samples for serum 25[OH]D, serum electrolytes, calcium, phosphorous, parathyroid hormone, cholesterol, triglycerides, plasma lycopene, plasma beta carotene, and bone turnover biomarkers. Participants will be given the choice to donate optional samples of saliva and/or 24 hour urine collection. For these optional samples, researchers will quantify vitamin D metabolites (7-DHC, 1,25(OH)2D, 24,25(OH)2D, and C-3 epi 25(OH)D) in saliva and urine as well as vitamin D binding protein in saliva.
Participants will consume one of four soups everyday for 21-days. The four soups are described as such:
- Soup with precision bred tomatoes biofortified with provitamin D (7-dehydrocholesterol-rich, No UV-Treatment). This soup is made with precision bred tomatoes. Tomatoes have been engineered to accumulate 7-dehydrocholesterol (7-DHC, also called provitamin D, a precursor of vitamin D3). The bioefficacy of the provitamin D in the diet is largely unknown.
- Soup with precision bred tomatoes (Vitamin D-rich, UV-Treated) This soup is made with the same precision bred tomatoes, but in this case, the tomatoes have been treated with ultraviolet (UV) light to convert the accumulated 7-DHC into vitamin D3. UV exposure mimics the natural process by which human skin synthesizes vitamin D3 from sunlight.
- Soup with store bought tomatoes (placebo). In this soup, store bought conventional tomatoes contain negligible amounts of 7-DHC and no vitamin D3. This soup is the placebo soup.
- Soup with store bought tomatoes supplemented with Vitamin D3. In this soup, same store-bought tomatoes will be supplemented with vitamin D (from lanolin).
- Conditions
- Vitamin D Insufficiency
- Being tested
- Precision Bred Provitamin D-rich Tomato Soup, Precision Bred Vitamin D-rich Tomato Soup, Wild-type (store-bought) Tomato Soup, Wild-type (store-bought) Tomato with vitamin D supplementation Soup
- Keywords
- tomato soup, precision breeding, biofortification, vitamin D, 25-hydroxy vitamin D (25[OH]D), dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Bred Provitamin D-rich Tomato SoupOther
Participants will consume one tomato soup every day for 21 days as part of their normal diet.
Precision Bred Vitamin D-rich Tomato SoupOther
Participants will consume one tomato soup everyday for 21-days as part of their normal diet.
Wild-type (store-bought) Tomato SoupOther
Participants will consume one tomato soup every day for 21 days as part of their normal diet.
Wild-type (store-bought) Tomato with vitamin D supplementation SoupOther
Participants will consume one tomato soup everyday for 21 days as part of their normal diet.
| Study group | Role | What they receive |
|---|---|---|
| Soup with Precision Bred Tomatoes (Provitamin D-rich, No UV-Treatment) | Experimental | Soup made with precision bred (gene-edited) tomatoes that have been engineered to accumulate 7-dehydrocholesterol (7-DHC) also known as provitamin D is a precursor of vitamin D3. These tomatoes have undergone CRISPR-Cas9 gene editing to allow the accumulation of 7-DHC in the tomatoes and remains to be rich in 7-DHC when protected from UV light. Receives: Other: Precision Bred Provitamin D-rich Tomato Soup |
| Soup with Precision Bred Tomatoes (Vitamin D-rich, UV-Treated) | Experimental | Soup is made with the same precision bred tomatoes, but in this case, the tomatoes have been treated with ultraviolet (UV) light to convert the accumulated 7-DHC into vitamin D3. UV exposure mimics the natural process by which human skin synthesizes vitamin D3 from sunlight. Receives: Other: Precision Bred Vitamin D-rich Tomato Soup |
| Soup Made with Wild-Type (Store-bought) Tomatoes | Placebo comparator | In this soup, store-bought (wild-type) tomatoes contain negligible amounts of 7-DHC and no vitamin D3. Receives: Other: Wild-type (store-bought) Tomato Soup |
| Soup Made with Wild-Type (Store-bought) Tomatoes with Vitamin D3 Supplement | Active comparator | In this soup, store-bought (wild-type) tomatoes are used and supplemented with vitamin D3 (lanolin). Receives: Other: Wild-type (store-bought) Tomato with vitamin D supplementation Soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma lycopene and beta carotene to assess adherence
Fasting plasma total carotenoids and total lycopene
Measured: Day 0 and Day 21
Differences in soup acceptability using sensory evaluation questionnaires as a measure of adherence
Soup acceptability will be measured using a 9-point hedonic scale and 5 point Just-about-Right scale
Measured: Screening visit (Day -60 to -1), Day 1, and Day 21
Assess changes in eating pattern due to daily consumption of soup
VioScreen Food frequency questionnaire
Measured: Day 0 and Day 21
Changes in serum 25-hydroxy vitamin D (25(OH)D) to monitor safety
Fasting serum 25(OH)D levels
Measured: Day 0 and Day 21
Changes in serum electrolytes, calcium and phosphorous to monitor safety
Fasting serum electrolytes, calcium and phosphorus
Measured: Day 0 and Day 21
Change in parathyroid hormone to assess safety
Fasting plasma parathyroid hormone
Measured: Day 0 and Day 21
Assess change in bone turnover biomarkers on serum 25(OH)D levels
Fasting serum procollagen Type 1 N-Terminal Propeptide and Collagen Type 1 Cross-Linked C Telopeptide (P1NP and CTx)
Measured: Day 0 and Day 21
Measure changes in sunlight exposure
Quantify sunlight exposure using Outdoor Skin Assessment, Sun-a-Wear UV tracker UV (duration UV exposure and UV Index)
Measured: Day 0 and Day 21
Measure changes in physical activity
Physical activity will be measured using the International Physical Activity Questionnaire - short version
Measured: Day 0 and Day 21
Secondary outcomes (4)
Treatment effects of daily tomato soup consumption on vitamin D3 or its precursor (7-DHC) on serum 25(OH)D, PTH, cholesterol
Fasting serum 25(OH)D levels Fasting plasma PTH Fasting serum cholesterol, triglycerides, and 25(OH)D levels
Measured: Day 21
Quantify differences in vitamin D metabolites
Vitamin D metabolites measured in serum and urine are provitamin (7-DHC), 1,25(OH)2D, 24,25(OH)2D, and C-3 epi 25(OH)D)
Measured: Day 0 and Day 21
Changes in the quantity of vitamin D and their binding proteins in saliva
Vitamin D metabolites (provitamin (7-DHC), 1,25(OH)2D, 24,25(OH)2D, and C-3 epi 25(OH)D) will be measured in non-stimulated and stimulated saliva Vitamin D binding protein will be measured in non-stimulated and stimulated saliva
Measured: Day 0 and Day 21
Correlate salivary vitamin D and salivary vitamin D binding protein and serum 25(OH)D levels
Vitamin D metabolites (provitamin (7-DHC), 1,25(OH)2D, 24,25(OH)2D, and C-3 epi 25(OH)D) in non-stimulated and stimulated saliva collection Fasting serum 25(OH)D
Measured: Day 0 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D InsufficiencyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey, John Innes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, NIHR Norfolk Clinical Research Facility
- Responsible party
- Sponsor
- Investigators
- Martin Warren, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142759
- Sponsor's protocol ID
- QIB03/2024
- Other IDs
- IRAS 349335
- Acronym
- ViTaL-D
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data which complies with General Data Protection Regulations will be shared
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Vitamin D Biofortified Tomatoes on Serum Levels of 25(OH)D - a Two Phase, a Randomized Double-blind Placebo-controlled Parallel Arm Trial (RCT)
- ClinicalTrials.gov ID
- NCT07142759
- Acronym / sponsor ID
- ViTaL-D / QIB03/2024
- Conditions
- Vitamin D Insufficiency
- Keywords
- tomato soup, precision breeding, biofortification, vitamin D, 25-hydroxy vitamin D (25[OH]D), dietary intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- University of Surrey, John Innes Centre, Norfolk and Norwich University Hospitals NHS Foundation Trust, NIHR Norfolk Clinical Research Facility
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 27 Aug 2025 (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.
In the UK, vitamin D deficiency occurs frequently especially during the winter months. Vitamin D biofortified tomatoes have been developed using precision breeding technique by researchers at John Innes Centre. Biofortification uses crop breeding to increase the nutritional value of crops. The goal of the ViTaL-D study is to examine whether the vitamin D biofortified tomatoes when eaten as a soup can increase blood levels of vitamin D in men and women with vitamin D deficiency. Additionally, researchers will learn if the tomato soups are feasible and safe to eat everyday. The main questions the study aims to answer are:
- Does vitamin D biofortified tomatoes increase vitamin D levels in men and women with low blood levels of vitamin D?
- Is consuming vitamin D biofortified tomatoes safe and easy to eat everyday as a soup?
Researchers will compare how four types of tomato soup increase blood vitamin D levels. The four types of soup are:
- Soup with vitamin D biofortified tomatoes
- Soup with provitamin D biofortified tomatoes
- Soup with store-bought tomatoes not containing vitamin D
- Soup with store-bought tomatoes with added vitamin D
Participants will:
- Eat one of the four types of tomato soup every day for 21 days.
- Visit the clinic once every 7 days after a 12 hour fast for body measurements, tests, and surveys.
- Keep a daily diary when soups are eaten and when time is spent outside.
Detailed description
The ViTaL-D study is a 21-day randomized, double-blind, placebo-controlled four-arm parallel pilot study conducted at the NIHR (National Institute for Health and Care Research) Norfolk Clinical Research Facility (CRF) in the Quadram Institute in Norwich. Researchers are seeking adult (at least 18 years and older) men and women who have serum 25-hydroxyvitamin D (25[OH]D) levels between 25-40 nmol/L to determine whether soups made with precision bred, biofortified vitamin D tomatoes will increase vitamin D levels. There are a total of 6 study visits (1 consent visit, 1 screening visit, and 4 short visits). At these visits, anthropometric measurements and vital signs will be collected. Participants will be asked to complete questionnaires (food frequency, international physical activity, and sensory evaluation). They will record their daily consumption of soup as well as their daily sun exposure and wear a UV tracker when they are outdoors.
Researchers will measure fasting blood samples for serum 25[OH]D, serum electrolytes, calcium, phosphorous, parathyroid hormone, cholesterol, triglycerides, plasma lycopene, plasma beta carotene, and bone turnover biomarkers. Participants will be given the choice to donate optional samples of saliva and/or 24 hour urine collection. For these optional samples, researchers will quantify vitamin D metabolites (7-DHC, 1,25(OH)2D, 24,25(OH)2D, and C-3 epi 25(OH)D) in saliva and urine as well as vitamin D binding protein in saliva.
Participants will consume one of four soups everyday for 21-days. The four soups are described as such:
- Soup with precision bred tomatoes biofortified with provitamin D (7-dehydrocholesterol-rich, No UV-Treatment). This soup is made with precision bred tomatoes. Tomatoes have been engineered to accumulate 7-dehydrocholesterol (7-DHC, also called provitamin D, a precursor of vitamin D3). The bioefficacy of the provitamin D in the diet is largely unknown.
- Soup with precision bred tomatoes (Vitamin D-rich, UV-Treated) This soup is made with the same precision bred tomatoes, but in this case, the tomatoes have been treated with ultraviolet (UV) light to convert the accumulated 7-DHC into vitamin D3. UV exposure mimics the natural process by which human skin synthesizes vitamin D3 from sunlight.
- Soup with store bought tomatoes (placebo). In this soup, store bought conventional tomatoes contain negligible amounts of 7-DHC and no vitamin D3. This soup is the placebo soup.
- Soup with store bought tomatoes supplemented with Vitamin D3. In this soup, same store-bought tomatoes will be supplemented with vitamin D (from lanolin).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Soup with Precision Bred Tomatoes (Provitamin D-rich, No UV-Treatment) | Experimental | Other: Precision Bred Provitamin D-rich Tomato SoupSoup made with precision bred (gene-edited) tomatoes that have been engineered to accumulate 7-dehydrocholesterol (7-DHC) also known as provitamin D is a precursor of vitamin D3. These tomatoes have undergone CRISPR-Cas9 gene editing to allow the accumulation of 7-DHC in the tomatoes and remains to be rich in 7-DHC when protected from UV light. |
| Soup with Precision Bred Tomatoes (Vitamin D-rich, UV-Treated) | Experimental | Other: Precision Bred Vitamin D-rich Tomato SoupSoup is made with the same precision bred tomatoes, but in this case, the tomatoes have been treated with ultraviolet (UV) light to convert the accumulated 7-DHC into vitamin D3. UV exposure mimics the natural process by which human skin synthesizes vitamin D3 from sunlight. |
| Soup Made with Wild-Type (Store-bought) Tomatoes | Placebo comparator | Other: Wild-type (store-bought) Tomato SoupIn this soup, store-bought (wild-type) tomatoes contain negligible amounts of 7-DHC and no vitamin D3. |
| Soup Made with Wild-Type (Store-bought) Tomatoes with Vitamin D3 Supplement | Active comparator | Other: Wild-type (store-bought) Tomato with vitamin D supplementation SoupIn this soup, store-bought (wild-type) tomatoes are used and supplemented with vitamin D3 (lanolin). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be willing to eat a tomato soup daily for 21 days.
- Have access to a smartphone or tablet device and internet access.
- Be at least 18 years old
- Be able to understand the study and provide informed consent
- Have serum 25-hydroxyvitamin D (25[OH]D) levels between 25-40 nmol/L
Key exclusion criteria (15 listed)
- Have a known allergy or intolerance to tomatoes or to any of the soup components (tomatoes, milk, wheat, lanolin are the major allergens, but a detailed list is in Annex 16) of the test soups.
- Currently undergoing treatment or on medications for hypo/hypercalcaemia, hypo/hyperparathyroidism, kidney stones, or bone diseases.
- Have anaemia, immunocompromised or viral infections that may compromise immunity. This will be assessed on a case-by-case basis by QI medical advisor.
- Have any acute or chronic illnesses that affects the outcome of the study such as a gastrointestinal disorder. This will be assessed on a case-by-case basis by Quadram Institute medical advisor.
- Have just started taking or changed dose of vitamin D supplement in the month prior to the start of the intervention or at any point during the intervention, or are regularly taking more than 400 International Units (IU) of vitamin D.
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 |
|---|---|---|
| Precision Bred Provitamin D-rich Tomato SoupParticipants will consume one tomato soup every day for 21 days as part of their normal diet. | Other | Soup with Precision Bred Tomatoes (Provitamin D-rich, No UV-Treatment) |
| Precision Bred Vitamin D-rich Tomato SoupParticipants will consume one tomato soup everyday for 21-days as part of their normal diet. | Other | Soup with Precision Bred Tomatoes (Vitamin D-rich, UV-Treated) |
| Wild-type (store-bought) Tomato SoupParticipants will consume one tomato soup every day for 21 days as part of their normal diet. | Other | Soup Made with Wild-Type (Store-bought) Tomatoes |
| Wild-type (store-bought) Tomato with vitamin D supplementation SoupParticipants will consume one tomato soup everyday for 21 days as part of their normal diet. | Other | Soup Made with Wild-Type (Store-bought) Tomatoes with Vitamin D3 Supplement |
Primary outcome
Change in plasma lycopene and beta carotene to assess adherence
Time frame: Day 0 and Day 21
Fasting plasma total carotenoids and total lycopene
Differences in soup acceptability using sensory evaluation questionnaires as a measure of adherence
Time frame: Screening visit (Day -60 to -1), Day 1, and Day 21
Soup acceptability will be measured using a 9-point hedonic scale and 5 point Just-about-Right scale
Assess changes in eating pattern due to daily consumption of soup
Time frame: Day 0 and Day 21
VioScreen Food frequency questionnaire
Changes in serum 25-hydroxy vitamin D (25(OH)D) to monitor safety
Time frame: Day 0 and Day 21
Fasting serum 25(OH)D levels
Changes in serum electrolytes, calcium and phosphorous to monitor safety
Time frame: Day 0 and Day 21
Fasting serum electrolytes, calcium and phosphorus
Change in parathyroid hormone to assess safety
Time frame: Day 0 and Day 21
Fasting plasma parathyroid hormone
Assess change in bone turnover biomarkers on serum 25(OH)D levels
Time frame: Day 0 and Day 21
Fasting serum procollagen Type 1 N-Terminal Propeptide and Collagen Type 1 Cross-Linked C Telopeptide (P1NP and CTx)
Measure changes in sunlight exposure
Time frame: Day 0 and Day 21
Quantify sunlight exposure using Outdoor Skin Assessment, Sun-a-Wear UV tracker UV (duration UV exposure and UV Index)
Measure changes in physical activity
Time frame: Day 0 and Day 21
Physical activity will be measured using the International Physical Activity Questionnaire - short version
4 secondary outcomes
Treatment effects of daily tomato soup consumption on vitamin D3 or its precursor (7-DHC) on serum 25(OH)D, PTH, cholesterol
Time frame: Day 21
Quantify differences in vitamin D metabolites
Time frame: Day 0 and Day 21
Changes in the quantity of vitamin D and their binding proteins in saliva
Time frame: Day 0 and Day 21
Correlate salivary vitamin D and salivary vitamin D binding protein and serum 25(OH)D levels
Time frame: Day 0 and Day 21
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 27 Aug 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data which complies with General Data Protection Regulations will be shared
Related trials for Vitamin D Insufficiency
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Recruiting
Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs
Healthy Adult Participants, Vitamin D Insufficiency
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
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.
Martin Warren, PhD principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Bred Provitamin D-rich Tomato Soup, Precision Bred Vitamin D-rich Tomato Soup and Wild-type (store-bought) Tomato Soup in people with Vitamin D Insufficiency, run by Quadram Institute Bioscience 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 7 inclusion and 15 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 27 Aug 2025. 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?
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?
Change in plasma lycopene and beta carotene to assess adherence (time frame: Day 0 and Day 21). The study lists 9 primary outcomes in all. 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 27 Aug 2025.