Status:
RECRUITING
A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families
Lead Sponsor:
University College Cork
Collaborating Sponsors:
University College Dublin
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
5-59 years
Phase:
NA
Brief Summary
Vitamin D deficiency is common. It is caused by limited sun availability together with a low supply of vitamin D in the food system. There is a high prevalence of low vitamin D status around the world...
Detailed Description
This randomised controlled dietary intervention study aims to recruit households/families of children, teens and adults, with 390 participants who will be randomised to receive vitamin D-fortified bre...
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent if over 16 years; informed parental consent for children under-16 years, plus age-appropriate assent for children under-16 years.
- Be a household with at least one adult ≥18 years, with at least one dependent aged 5 years or older.
- Willing to consume bread provided and have storage capacity for frozen bread.
- Be in good general health.
- Be willing to follow the assigned diet for 8 weeks and attend the required appointments.
Exclusion Criteria:
- Daily consumption of a vitamin D supplement with a dose exceeding >10µg/d (400 IU) equivalent.
- Exposure to factors that may influence vitamin D status, such as winter sun holiday, ski holiday, tanning beds etc.
- Are following a medically prescribed diet.
- Have a diagnosis of a medical condition that may interfere with vitamin D absorption, such as Coeliac disease, Inflammatory Bowel Disease, cystic fibrosis, or metabolism, such as liver disease, renal disease.
- Have a history of active cancer or a diagnosis of cancer within the past 5 years.
- Have an allergy to the bread ingredients.
- Are participating in another research study with an intervention or other lifestyle programme that would interfere with the outcomes of the study.
- Are unable to read, write, or understand English.
Key Trial Info
Start Date :
November 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT07481240
Start Date
November 17 2025
End Date
March 31 2026
Last Update
March 18 2026
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Human Nutrition Studies Unit, School of Food and Nutritional Sciences
Cork, Co. Cork, Ireland, T12 K8AF
2
UCD Institute of Food and Health
Dublin, Ireland