A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families (NCT07481240) | Clinical Trial Compass
RecruitingNot Applicable
A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families
Ireland390 participantsStarted 2025-11-17
Plain-language 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. In Ireland, our relatively northern latitude and prevailing weather mean that UVB availability for skin synthesis of vitamin D is limited in this country and our population relies on the dietary supply of vitamin D to prevent deficiency. Thus, the endemic Irish problem of vitamin D malnutrition is due to the lack of vitamin D in our food system. Dietary guidelines cannot address this issue because foods naturally rich in vitamin D are very few and infrequently consumed.
The FamDBread study will test the hypothesis that a vitamin D-fortified bread as part of a healthy diet that includes vitamin D-fortified foods is effective in preventing low vitamin D status during winter, and safe for families to consume.
Who can participate
Age range5 Years – 59 Years
SexALL
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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.
What they're measuring
1
Serum concentrations of 25-hydroxyvitamin D (25(OH)D)
✕. 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.