Actively Recruiting

Phase Not Applicable
Age: 5Years - 59Years
All Genders
Healthy Volunteers
NCT07481240

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

Led by University College Cork · Updated on 2026-03-18

390

Participants Needed

2

Research Sites

19 weeks

Total Duration

On this page

Sponsors

U

University College Cork

Lead Sponsor

U

University College Dublin

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 5Years - 59Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent if over 16 years; parental consent and child assent for those under 16 years
  • Household must include at least one adult aged 18 or older and at least one dependent aged 5 years or older
  • Willing to consume the provided bread and have freezer space to store frozen bread
  • Be in good general health
  • Willing to follow the assigned diet for 8 weeks and attend all required appointments
Not Eligible

You will not qualify if you...

  • Daily intake of vitamin D supplements exceeding 10 micrograms (400 IU)
  • Recent exposure to factors affecting vitamin D status, such as winter sun holidays, ski holidays, or tanning beds
  • Following a medically prescribed diet
  • Diagnosed with medical conditions affecting vitamin D absorption or metabolism, including Coeliac disease, Inflammatory Bowel Disease, cystic fibrosis, liver or kidney disease
  • History of active cancer or cancer diagnosis within the past 5 years
  • Allergy to bread ingredients
  • Participating in another research study or lifestyle program that could affect study outcomes
  • Unable to read, write, or understand English

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Human Nutrition Studies Unit, School of Food and Nutritional Sciences

Cork, Co. Cork, Ireland, T12 K8AF

Not Yet Recruiting

2

UCD Institute of Food and Health

Dublin, Ireland

Actively Recruiting

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Research Team

M

Maired Kiely, PhD

CONTACT

K

Kevin Cashman, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families | DecenTrialz