A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families
Trial Parameters
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. 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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Be a household with at least one adult ≥18 years, with at least one dependent aged 5 years or older. 3. Willing to consume bread provided and have storage capacity for frozen bread. 4. Be in good general health. 5. Be willing to follow the assigned diet for 8 weeks and attend the required appointments. Exclusion Criteria: 1. Daily consumption of a vitamin D supplement with a dose exceeding \>10µg/d (400 IU) equivalent. 2. Exposure to factors that may influence vitamin D status, such as winter sun holiday, ski holiday, tanning beds etc. 3. Are following a medically prescribed diet. 4. 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. 5. Have a h