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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D3 eggs; Dietary Supplement: Control eggs; Dietary Supplement: 25-Hydroxyvitamin D3 eggs

• Registration Number: NCT02678364
• Lead Sponsor: University College Cork

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-08
• Last Update Submitted: 2016-02-08
• Study First Posted: 2016-02-09
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3-eggs group	Vitamin D3 eggs	Seven vitamin D3-biofortified eggs per week
Control egg group	Control eggs	Two or less control (non-biofortified) eggs per week
25-Hydroxyvitamin D-eggs group	25-Hydroxyvitamin D3 eggs	7 25-hydroxyvitamin D-biofortified eggs per week

Primary Outcome Measures

Name	Time	Method
Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter	up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Serum parathyroid hormone	0 weeks and 8 weeks

Trial Locations

Locations (1)

Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork; 🇮🇪 Cork, Ireland