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NCT Number: NCT02678364

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cork, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control eggs

Dietary Supplement

Control eggs containing no additional vitamin D beyond norm

Vitamin D3 eggs

Dietary Supplement

Vitamin D3-biofortified eggs

25-Hydroxyvitamin D3 eggs

Dietary Supplement

25-Hydroxyvitamin D3-biofortified eggs

Primary outcomes

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

    Time frame: up to 8 weeks

Secondary outcomes

  1. Serum parathyroid hormone

    Time frame: 0 weeks and 8 weeks

Other outcomes

  1. Serum total calcium

    Time frame: 0 weeks and 8 weeks

  2. Serum total cholesterol

    Time frame: 0 weeks and 8 weeks

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults

Acronym: EnhanceDeggs

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 9, 2016
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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