Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT07142759
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07142759
Study Brief:
Protocol Section:
NCT07142759