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

University College Cork (UCC)

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D3 eggs; Dietary Supplement: Control eggs; Dietary Supplement: 25-Hydroxyvitamin D3 eggs

Study type: Interventional

Funder types: Other

Identifiers

NCT02678364

ECM 4 (y) 07/10/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 3 patient groups, including a placebo group

Control egg group

Placebo Comparator group

Description:

Two or less control (non-biofortified) eggs per week

Treatment:

Dietary Supplement: Control eggs

Vitamin D3-eggs group

Active Comparator group

Description:

Seven vitamin D3-biofortified eggs per week

Treatment:

Dietary Supplement: Vitamin D3 eggs

25-Hydroxyvitamin D-eggs group

Active Comparator group

Description:

7 25-hydroxyvitamin D-biofortified eggs per week

Treatment:

Dietary Supplement: 25-Hydroxyvitamin D3 eggs