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Fam-D-Bread: A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 59
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Ireland
Human Nutrition Studies Unit, School of Food and Nutritional Sciences
NOT_YET_RECRUITING
Cork
UCD Institute of Food and Health
RECRUITING
Dublin
Contact Information
Primary
Maired Kiely, PhD
m.kiely@ucc.ie
00353214903394
Backup
Kevin Cashman, PhD
k.cashman@ucc.ie
00353214901317
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 390
Treatments
Experimental: Fortified bread Intervention group
Fortified bread Intervention group will be supplied with vitamin D fortified bread. Fortified Bread Intervention group will be supplied with fortified bread delivering \>20μg vitamin D3 in a daily portion and will receive dietary advice to incorporate fortified foods that are commonly available on the market in their diet.
Placebo_comparator: Placebo Comparator
Control arm will receive unfortified bread and dietary advice to incorporate fortified foods that are commonly available on the market in their diet.
Related Therapeutic Areas
Sponsors
Leads: University College Cork
Collaborators: University College Dublin

This content was sourced from clinicaltrials.gov