A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University College Cork
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter
Study Overview
Brief Summary
While there have been a considerable number of studies on the impact of additional vitamin D in the diets of hens on the resulting egg vitamin D content, the effect of consumption of such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been tested in a RCT.
Detailed Description
The aim of this study was to investigate the effect of consumption of vitamin D3 versus 25-hydroxyvitamin D3 biofortified eggs on winter serum 25(OH)D in adults using a 8-wk randomized controlled trial. This research will provide new data on the potential of vitamin D enriched eggs as a food-based strategy for prevention of vitamin D deficiency.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •consenting white men and women aged 45-70 years
Exclusion Criteria
- •consumption of vitamin D-containing supplements throughout the study. planning to take a winter vacation (during the course of the 8-wk intervention) - to a location at which either the altitude or the latitude would be predicted to result in significant cutaneous vitamin D synthesis from solar radiation
- •planning to use tanning facilities of any type.
- •a severe medical illness,
- •allergy to egg products,
- •medically advised to limit egg intake in relation to managing hypercholesterolemia,
- •hypercalcaemia,
- •known intestinal malabsorption syndrome,
- •excessive alcohol use,
- •the use of medications known to interfere with vitamin D metabolism
Arms & Interventions
Control egg group
Two or less control (non-biofortified) eggs per week
Intervention: Control eggs (Dietary Supplement)
Vitamin D3-eggs group
Seven vitamin D3-biofortified eggs per week
Intervention: Vitamin D3 eggs (Dietary Supplement)
25-Hydroxyvitamin D-eggs group
7 25-hydroxyvitamin D-biofortified eggs per week
Intervention: 25-Hydroxyvitamin D3 eggs (Dietary Supplement)
Outcomes
Primary Outcomes
Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter
Time Frame: up to 8 weeks
Secondary Outcomes
- Serum parathyroid hormone(0 weeks and 8 weeks)
Investigators
Kevin D. Cashman
Professor of Food and Health
University College Cork