Vitamin D DeficiencyEnhanceDeggsNCT02678364
Effect of Vitamin D-biofortified Eggs on Wintertime Serum 25-hydroxyvitamin D in Adults: Randomized Controlled Trial
A study testing Vitamin D3 eggs and 25-Hydroxyvitamin D3 eggs in people with Vitamin D Deficiency, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3 eggs and 25-Hydroxyvitamin D3 eggs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- consenting white men and women aged 45-70 years
Who cannot join
- 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,
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- known intestinal malabsorption syndrome,
- excessive alcohol use,
- the use of medications known to interfere with vitamin D metabolism
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Human Dietary Studies Facility, School of Food and Nutritional Sciences, University College Cork
Cork
About this study
Official title: A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Control eggs, Vitamin D3 eggs, 25-Hydroxyvitamin D3 eggs
- Keywords
- Vitamin D-biofortified eggs, Vitamin D status, RCT
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control eggsDietary supplement
Control eggs containing no additional vitamin D beyond norm
Vitamin D3 eggsDietary supplement
Vitamin D3-biofortified eggs
25-Hydroxyvitamin D3 eggsDietary supplement
25-Hydroxyvitamin D3-biofortified eggs
| Study group | Role | What they receive |
|---|---|---|
| Control egg group | Placebo comparator | Two or less control (non-biofortified) eggs per week Receives: Dietary Supplement: Control eggs |
| Vitamin D3-eggs group | Active comparator | Seven vitamin D3-biofortified eggs per week Receives: Dietary Supplement: Vitamin D3 eggs |
| 25-Hydroxyvitamin D-eggs group | Active comparator | 7 25-hydroxyvitamin D-biofortified eggs per week Receives: Dietary Supplement: 25-Hydroxyvitamin D3 eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter
Measured: up to 8 weeks
Secondary outcomes (1)
Serum parathyroid hormone
Measured: 0 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin D. Cashman, University College Cork
- Investigators
- Kevin D Cashman, BSc, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678364
- Sponsor's protocol ID
- ECM 4 (y) 07/10/14
- Acronym
- EnhanceDeggs
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 27488236
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary Intervention Study Examining the Effect of Consumption of Vitamin D-enhanced Eggs on Winter-time Vitamin D Status in Adults
- ClinicalTrials.gov ID
- NCT02678364
- Acronym / sponsor ID
- EnhanceDeggs / ECM 4 (y) 07/10/14
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D-biofortified eggs, Vitamin D status, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control egg group | Placebo comparator | Dietary Supplement: Control eggsTwo or less control (non-biofortified) eggs per week |
| Vitamin D3-eggs group | Active comparator | Dietary Supplement: Vitamin D3 eggsSeven vitamin D3-biofortified eggs per week |
| 25-Hydroxyvitamin D-eggs group | Active comparator | Dietary Supplement: 25-Hydroxyvitamin D3 eggs7 25-hydroxyvitamin D-biofortified eggs per week |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consenting white men and women aged 45-70 years
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control eggsControl eggs containing no additional vitamin D beyond norm | Dietary supplement | Control egg group |
| Vitamin D3 eggsVitamin D3-biofortified eggs | Dietary supplement | Vitamin D3-eggs group |
| 25-Hydroxyvitamin D3 eggs25-Hydroxyvitamin D3-biofortified eggs | Dietary supplement | 25-Hydroxyvitamin D-eggs group |
Primary outcome
Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter
Time frame: up to 8 weeks
1 secondary outcome
Serum parathyroid hormone
Time frame: 0 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Derived from this study: PubMed 27488236Hayes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin D Cashman, BSc, PhD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 eggs and 25-Hydroxyvitamin D3 eggs in people with Vitamin D Deficiency, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of serum total 25-hydroxyvitamin D concentration over 8 weeks of winter (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.