A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families
NCT07481240 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2026-05-15
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.
Conditions
- Vitamin D Deficiency
Interventions
- OTHER
-
Fortified Bread
Intervention group will be supplied with fortified bread delivering \>20 μg 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.
- OTHER
-
Unfortified bread
Placebo control group will be supplied with unfortified bread and will receive dietary advice to incorporate fortified foods that are commonly available on the market in their diet.
Sponsors & Collaborators
-
University College Dublin
collaborator OTHER -
University College Cork
lead OTHER
Principal Investigators
-
Mairead Kiely, PhD · University College Cork
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-17
- Primary Completion
- 2026-04-04
- Completion
- 2026-04-04
Countries
- Ireland
Study Locations
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