Vitamin D DeficiencyNCT04207294
Vitamin D Enriched Meat Project (Acute Study)
A study testing Pork arm and Chicken arm in people with Vitamin D Deficiency, run by University of Ulster at 1 site in United Kingdom.
Trial summary
The importance of achieving an adequate vitamin D status is widely recognised, with public health and research communities heightening their interest over recent years. Whilst vitamin D can be synthesised following skin exposure to UV light, due to public health concerns regarding sun safety, and modern indoor… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Pork arm and Chicken arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2020to 10 Apr 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- · Free-living, apparently healthy Caucasian adults
- Aged 18-65 years at Recruitment
- Body Mass Index (BMI) ≥18.5 and <25kg/m2
- If consuming vitamin D supplements, willing to discontinue 4 weeks prior and for duration of study
- Non-smokers
Who cannot join
- · Non-Caucasian adults
- Adults <18 or >65 years at recruitment
- Taking vitamin D supplement and not willing to discontinue vitamin D supplementation for 4 weeks prior to and for duration of study
- Current smokers
- Pregnant/lactating females
- Use of tanning facilities or winter vacation planned during the intervention period to a location expected to increase cutaneous synthesis
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- Severe medical illness
- Medications which interfere with vitamin D metabolism e.g. steroid medications (e.g. prednisone), weight loss drug orlistat (e.g. Xenical and Alli), cholesterol-lowering drug cholestyramine (e.g. Questran, LoCholest and Prevalite), seizure drugs Phenobarbital and Dilantin, anti-tuberculosis, statins or thiazide diuretics
- Intestinal malabsorption syndrome
- Excessive alcohol use (>14 units/ week)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
Official title: Bioavailability of Vitamin D-enriched Pork and Chicken in Comparison to a Vitamin D Supplement in Healthy Adults: an Acute Study
The importance of achieving an adequate vitamin D status is widely recognised, with public health and research communities heightening their interest over recent years.
Whilst vitamin D can be synthesised following skin exposure to UV light, due to public health concerns regarding sun safety, and modern indoor lifestyles, it has become evident that endogenous synthesis may not be an effective means of maintaining an adequate vitamin D status across the year. Given the marked variation in seasonally-induced cutaneous synthesis, habitually low dietary vitamin D intakes of 2-4µg/day typically reported within nationally represented population surveys, and the generally low uptake of supplementation at the population level, it is warranted to identify alternative food-based strategies to yield greater adherence to the 10µg DRV, particularly during winter months where sunlight exposure is negligible. Commodity-based biofortification may provide an innovative and viable additional food-based approach to suboptimal vitamin D status, in combination with safe sun exposure, inclusion of natural and fortified dietary sources and/or supplementation.
Read more
Meat naturally contains vitamin D3 and 25(OH)D3, yet by manipulating feeding regimes and/ or housing environments, it is possible to improve the concentration of both metabolites in animal products. Eggs, beef and pork provide viable opportunities for the enhancement of vitamin D3 and 25(OH)D3 which contribute to an increase in total vitamin D activity (vitamin D3 + [25(OH)D3 x 5]), and therefore would be expected to positively impact vitamin D status. Albeit whilst much biofortification research has been established, less is known regarding its effectiveness at raising circulating serum 25(OH)D concentrations amongst apparently healthy adults, with the exception of some plant-based foods.
Therefore, an opportunity exists to understand the bioavailability of vitamin D-enriched pork and vitamin D-enriched chicken to increase 25(OH)D concentration.
- Conditions
- Vitamin D Deficiency
- Being tested
- Pork arm, Chicken arm
- Keywords
- Vitamin D, Pork, Chicken, Bioavailability, 25 hydroxyvitamin D, Adults, RCT, Crossover
- 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.
Pork armOther
The effect of 1 portion of vitamin D-enriched pork on 25(OH)D concentration in comparison to a vitamin D supplement and control pork.
Chicken armOther
The effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D-enriched pork | Experimental | One portion of Vitamin D-enriched pork Receives: Other: Pork arm |
| Control pork | Placebo comparator | One portion of control pork Receives: Other: Pork arm |
| Vitamin D supplement | Active comparator | Equivocal dose of Vitamin D supplement Receives: Other: Pork arm |
| Vitamin D-enriched chicken | Experimental | One portion of Vitamin D-enriched chicken Receives: Other: Chicken arm |
| Control chicken | Placebo comparator | One portion of control chicken Receives: Other: Chicken arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D concentration
Vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2) (nmol/L) in serum/plasma
Measured: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)
Secondary outcomes (2)
Calcium serum concentrations
Adjusted calcium
Measured: Monitored over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)
Parathyroid hormone (PTH) concentration
Plasma levels
Measured: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start16 Jan 2020
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Devenish Nutrition, Lagan House, 19 Clarendon Road, Belfast, BT1 3BG, Agri-Food and Biosciences Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207294
- Sponsor's protocol ID
- REC/19/0040
- Status last verified
- Jun 2021
- First submitted
- 18 Dec 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin D-enriched Pork and Chicken in Comparison to a Vitamin D Supplement in Healthy Adults: an Acute Study
- ClinicalTrials.gov ID
- NCT04207294
- Acronym / sponsor ID
- REC/19/0040
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Pork, Chicken, Bioavailability, 25 hydroxyvitamin D, Adults, RCT, Crossover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Devenish Nutrition, Lagan House, 19 Clarendon Road, Belfast, BT1 3BG, Agri-Food and Biosciences Institute
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 20 Dec 2019 (actual)
- 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.
The importance of achieving an adequate vitamin D status is widely recognised, with public health and research communities heightening their interest over recent years.
Whilst vitamin D can be synthesised following skin exposure to UV light, due to public health concerns regarding sun safety, and modern indoor lifestyles, it has become evident that endogenous synthesis may not be an effective means of maintaining an adequate vitamin D status across the year. Given the marked variation in seasonally-induced cutaneous synthesis, habitually low dietary vitamin D intakes of 2-4µg/day typically reported within nationally represented population surveys, and the generally low uptake of supplementation at the population level, it is warranted to identify alternative food-based strategies to yield greater adherence to the 10µg DRV, particularly during winter months where sunlight exposure is negligible. Commodity-based biofortification may provide an innovative and viable additional food-based approach to suboptimal vitamin D status, in combination with safe sun exposure, inclusion of natural and fortified dietary sources and/or supplementation.
Meat naturally contains vitamin D3 and 25(OH)D3, yet by manipulating feeding regimes and/ or housing environments, it is possible to improve the concentration of both metabolites in animal products. Eggs, beef and pork provide viable opportunities for the enhancement of vitamin D3 and 25(OH)D3 which contribute to an increase in total vitamin D activity (vitamin D3 + [25(OH)D3 x 5]), and therefore would be expected to positively impact vitamin D status. Albeit whilst much biofortification research has been established, less is known regarding its effectiveness at raising circulating serum 25(OH)D concentrations amongst apparently healthy adults, with the exception of some plant-based foods.
Therefore, an opportunity exists to understand the bioavailability of vitamin D-enriched pork and vitamin D-enriched chicken to increase 25(OH)D concentration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vitamin D-enriched pork | Experimental | Other: Pork armOne portion of Vitamin D-enriched pork |
| Control pork | Placebo comparator | Other: Pork armOne portion of control pork |
| Vitamin D supplement | Active comparator | Other: Pork armEquivocal dose of Vitamin D supplement |
| Vitamin D-enriched chicken | Experimental | Other: Chicken armOne portion of Vitamin D-enriched chicken |
| Control chicken | Placebo comparator | Other: Chicken armOne portion of control chicken |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- · Free-living, apparently healthy Caucasian adults
Key exclusion criteria (10 listed)
- · Non-Caucasian adults
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 |
|---|---|---|
| Pork armThe effect of 1 portion of vitamin D-enriched pork on 25(OH)D concentration in comparison to a vitamin D supplement and control pork. | Other | Control pork, Vitamin D supplement, Vitamin D-enriched pork |
| Chicken armThe effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken. | Other | Control chicken, Vitamin D-enriched chicken |
Primary outcome
Change in vitamin D concentration
Time frame: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)
Vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2) (nmol/L) in serum/plasma
2 secondary outcomes
Calcium serum concentrations
Time frame: Monitored over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)
Parathyroid hormone (PTH) concentration
Time frame: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)
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 14 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pork arm and Chicken arm in people with Vitamin D Deficiency, run by University of Ulster at 1 site in United Kingdom.
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 5 inclusion and 10 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 14 Jun 2021. 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 United Kingdom. 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?
Change in vitamin D concentration (time frame: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2021; AzTrials last refreshed its copy on 3 Nov 2026.