NCT02678364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

February 5, 2016

Last Update Submit

February 8, 2016

Conditions

Vitamin D Deficiency

Keywords

Vitamin D-biofortified eggsVitamin D statusRCT

Outcome Measures

Primary Outcomes (1)

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

    up to 8 weeks

Secondary Outcomes (1)

  • Serum parathyroid hormone

    0 weeks and 8 weeks

Other Outcomes (2)

  • Serum total calcium

    0 weeks and 8 weeks

  • Serum total cholesterol

    0 weeks and 8 weeks

Study Arms (3)

Control egg group

PLACEBO COMPARATOR

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

Dietary Supplement: Control eggs

Vitamin D3-eggs group

ACTIVE COMPARATOR

Seven vitamin D3-biofortified eggs per week

Dietary Supplement: Vitamin D3 eggs

25-Hydroxyvitamin D-eggs group

ACTIVE COMPARATOR

7 25-hydroxyvitamin D-biofortified eggs per week

Dietary Supplement: 25-Hydroxyvitamin D3 eggs

Interventions

Control eggsDIETARY_SUPPLEMENT

Control eggs containing no additional vitamin D beyond norm

Control egg group
Vitamin D3 eggsDIETARY_SUPPLEMENT

Vitamin D3-biofortified eggs

Vitamin D3-eggs group
25-Hydroxyvitamin D3 eggsDIETARY_SUPPLEMENT

25-Hydroxyvitamin D3-biofortified eggs

25-Hydroxyvitamin D-eggs group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- consenting white men and women aged 45-70 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cork, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 27488236DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Kevin D Cashman, BSc, PhD

    University College Cork

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Food and Health

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 9, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)