Status:

RECRUITING

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

Lead Sponsor:

University College Cork

Collaborating Sponsors:

University College Dublin

Conditions:

Vitamin D Deficiency

Eligibility:

All Genders

5-59 years

Phase:

NA

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...

Detailed Description

This randomised controlled dietary intervention study aims to recruit households/families of children, teens and adults, with 390 participants who will be randomised to receive vitamin D-fortified bre...

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 history of active cancer or a diagnosis of cancer within the past 5 years.
  6. Have an allergy to the bread ingredients.
  7. Are participating in another research study with an intervention or other lifestyle programme that would interfere with the outcomes of the study.
  8. Are unable to read, write, or understand English.

Key Trial Info

Start Date :

November 17 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2026

Estimated Enrollment :

390 Patients enrolled

Trial Details

Trial ID

NCT07481240

Start Date

November 17 2025

End Date

March 31 2026

Last Update

March 18 2026

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Human Nutrition Studies Unit, School of Food and Nutritional Sciences

Cork, Co. Cork, Ireland, T12 K8AF

2

UCD Institute of Food and Health

Dublin, Ireland