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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Control eggs
Vitamin D3 eggs
25-Hydroxyvitamin D3 eggs
Sponsored by
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D-biofortified eggs, Vitamin D status, RCT

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control egg group

Vitamin D3-eggs group

25-Hydroxyvitamin D-eggs group

Arm Description

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

Seven vitamin D3-biofortified eggs per week

7 25-hydroxyvitamin D-biofortified eggs per week

Outcomes

Primary Outcome Measures

Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter

Secondary Outcome Measures

Serum parathyroid hormone

Full Information

First Posted
February 5, 2016
Last Updated
February 8, 2016
Sponsor
University College Cork
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1. Study Identification

Unique Protocol Identification Number
NCT02678364
Brief Title
Effect of Vitamin D-biofortified Eggs on Wintertime Serum 25-hydroxyvitamin D in Adults: Randomized Controlled Trial
Acronym
EnhanceDeggs
Official Title
A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D-biofortified eggs, Vitamin D status, RCT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control egg group
Arm Type
Placebo Comparator
Arm Description
Two or less control (non-biofortified) eggs per week
Arm Title
Vitamin D3-eggs group
Arm Type
Active Comparator
Arm Description
Seven vitamin D3-biofortified eggs per week
Arm Title
25-Hydroxyvitamin D-eggs group
Arm Type
Active Comparator
Arm Description
7 25-hydroxyvitamin D-biofortified eggs per week
Intervention Type
Dietary Supplement
Intervention Name(s)
Control eggs
Intervention Description
Control eggs containing no additional vitamin D beyond norm
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 eggs
Intervention Description
Vitamin D3-biofortified eggs
Intervention Type
Dietary Supplement
Intervention Name(s)
25-Hydroxyvitamin D3 eggs
Intervention Description
25-Hydroxyvitamin D3-biofortified eggs
Primary Outcome Measure Information:
Title
Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Serum parathyroid hormone
Time Frame
0 weeks and 8 weeks
Other Pre-specified Outcome Measures:
Title
Serum total calcium
Time Frame
0 weeks and 8 weeks
Title
Serum total cholesterol
Time Frame
0 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin D Cashman, BSc, PhD
Organizational Affiliation
University College Cork
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork
City
Cork
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27488236
Citation
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.
Results Reference
derived

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

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