Effect of Vitamin D-biofortified Eggs on Wintertime Serum 25-hydroxyvitamin D in Adults: Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Control eggs
* Dietary Supplement: Vitamin D3 eggs
* Dietary Supplement: 25-Hydroxyvitamin D3 eggs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control egg group<br>Two or less control (non-biofortified) eggs per week | Dietary Supplement: Control eggs<br>* Control eggs containing no additional vitamin D beyond norm<br>|
| Active Comparator: Vitamin D3-eggs group<br>Seven vitamin D3-biofortified eggs per week | Dietary Supplement: Vitamin D3 eggs<br>* Vitamin D3-biofortified eggs<br>|
| Active Comparator: 25-Hydroxyvitamin D-eggs group<br>7 25-hydroxyvitamin D-biofortified eggs per week | Dietary Supplement: 25-Hydroxyvitamin D3 eggs<br>* 25-Hydroxyvitamin D3-biofortified eggs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter |  | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum parathyroid hormone |  | 0 weeks and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D-biofortified eggs, Vitamin D status, RCT