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

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ClinicalTrials.gov Identifier: NCT02678364
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Kevin D. Cashman, University College Cork

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date February 9, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter [ Time Frame: up to 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Serum parathyroid hormone [ Time Frame: 0 weeks and 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2016)
  • Serum total calcium [ Time Frame: 0 weeks and 8 weeks ]
  • Serum total cholesterol [ Time Frame: 0 weeks and 8 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin D-biofortified Eggs on Wintertime Serum 25-hydroxyvitamin D in Adults: Randomized Controlled Trial
Official Title  ICMJE A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Dietary Supplement: Control eggs
    Control eggs containing no additional vitamin D beyond norm
  • Dietary Supplement: Vitamin D3 eggs
    Vitamin D3-biofortified eggs
  • Dietary Supplement: 25-Hydroxyvitamin D3 eggs
    25-Hydroxyvitamin D3-biofortified eggs
Study Arms  ICMJE
  • Placebo Comparator: Control egg group
    Two or less control (non-biofortified) eggs per week
    Intervention: Dietary Supplement: Control eggs
  • Active Comparator: Vitamin D3-eggs group
    Seven vitamin D3-biofortified eggs per week
    Intervention: Dietary Supplement: Vitamin D3 eggs
  • Active Comparator: 25-Hydroxyvitamin D-eggs group
    7 25-hydroxyvitamin D-biofortified eggs per week
    Intervention: Dietary Supplement: 25-Hydroxyvitamin D3 eggs
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2016)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678364
Other Study ID Numbers  ICMJE ECM 4 (y) 07/10/14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kevin D. Cashman, University College Cork
Study Sponsor  ICMJE University College Cork
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kevin D Cashman, BSc, PhD University College Cork
PRS Account University College Cork
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP