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

NCT ID: NCT02678364

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control egg group

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

Group Type: PLACEBO_COMPARATOR

Control eggs

Intervention Type: DIETARY_SUPPLEMENT

Control eggs containing no additional vitamin D beyond norm

Vitamin D3-eggs group

Seven vitamin D3-biofortified eggs per week

Group Type: ACTIVE_COMPARATOR

Vitamin D3 eggs

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3-biofortified eggs

25-Hydroxyvitamin D-eggs group

7 25-hydroxyvitamin D-biofortified eggs per week

Group Type: ACTIVE_COMPARATOR

25-Hydroxyvitamin D3 eggs

Intervention Type: DIETARY_SUPPLEMENT

25-Hydroxyvitamin D3-biofortified eggs

Interventions

Control eggs

Control eggs containing no additional vitamin D beyond norm

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 eggs

Vitamin D3-biofortified eggs

Intervention Type: DIETARY_SUPPLEMENT

25-Hydroxyvitamin D3 eggs

25-Hydroxyvitamin D3-biofortified eggs

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College Cork

OTHER

Sponsor Role: lead

Responsible Party

Kevin D. Cashman

Professor of Food and Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin D Cashman, BSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Locations

Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork

Cork, , Ireland

Countries

Ireland

References

Hayes A, Duffy S, O'Grady M, Jakobsen J, Galvin K, Teahan-Dillon J, Kerry J, Kelly A, O'Doherty J, Higgins S, Seamans KM, Cashman KD. Vitamin D-enhanced eggs are protective of wintertime serum 25-hydroxyvitamin D in a randomized controlled trial of adults. Am J Clin Nutr. 2016 Sep;104(3):629-37. doi: 10.3945/ajcn.116.132530. Epub 2016 Aug 3.

Reference Type: DERIVED

PMID: 27488236 (View on PubMed)

Other Identifiers

ECM 4 (y) 07/10/14

Identifier Type: -

Identifier Source: org_study_id