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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Control eggs Dietary Supplement: Vitamin D3 eggs Dietary Supplement: 25-Hydroxyvitamin D3 eggs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Placebo Comparator: Control egg group
Two or less control (non-biofortified) eggs per week
Dietary Supplement: Control eggs
Control eggs containing no additional vitamin D beyond norm

Active Comparator: Vitamin D3-eggs group
Seven vitamin D3-biofortified eggs per week
Dietary Supplement: Vitamin D3 eggs
Vitamin D3-biofortified eggs

Active Comparator: 25-Hydroxyvitamin D-eggs group
7 25-hydroxyvitamin D-biofortified eggs per week
Dietary Supplement: 25-Hydroxyvitamin D3 eggs
25-Hydroxyvitamin D3-biofortified eggs




Primary Outcome Measures :
  1. Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter [ Time Frame: up to 8 weeks ]

Secondary Outcome Measures :
  1. Serum parathyroid hormone [ Time Frame: 0 weeks and 8 weeks ]

Other Outcome Measures:
  1. Serum total calcium [ Time Frame: 0 weeks and 8 weeks ]
  2. Serum total cholesterol [ Time Frame: 0 weeks and 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678364


Locations
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Ireland
Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork
Cork, Ireland
Sponsors and Collaborators
University College Cork
Investigators
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Principal Investigator: Kevin D Cashman, BSc, PhD University College Cork
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kevin D. Cashman, Professor of Food and Health, University College Cork
ClinicalTrials.gov Identifier: NCT02678364    
Other Study ID Numbers: ECM 4 (y) 07/10/14
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kevin D. Cashman, University College Cork:
Vitamin D-biofortified eggs
Vitamin D status
RCT
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents