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

Vitamin D Deficiency Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678364
• Other study ID #: ECM 4 (y) 07/10/14
• Status: Completed
• Phase: N/A
• First received: February 5, 2016
• Last updated: February 8, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Control eggs
Control eggs containing no additional vitamin D beyond norm
• Vitamin D3 eggs
Vitamin D3-biofortified eggs
• 25-Hydroxyvitamin D3 eggs
25-Hydroxyvitamin D3-biofortified eggs

Locations

Country	Name	City	State
Ireland	Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum total calcium		0 weeks and 8 weeks	Yes
Other	Serum total cholesterol		0 weeks and 8 weeks	Yes
Primary	Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter		up to 8 weeks	No
Secondary	Serum parathyroid hormone		0 weeks and 8 weeks	No