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CompletedNCT04207294Updated Jun 14, 2021

Vitamin D Enriched Meat Project (Acute Study)

An interventional study of Pork arm and Chicken arm in Vitamin D Deficiency, sponsored by University of Ulster. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by University of Ulster · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Vitamin D Deficiency

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Keywords

  • Vitamin D
  • Pork
  • Chicken
  • Bioavailability
  • 25 hydroxyvitamin D
  • Adults
  • RCT
  • Crossover
03

In context

Vitamin D Deficiency

772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's enrollment of 15 is below the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

University of Ulster is the lead sponsor of 94 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • 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

Exclusion criteria

Exclusion Criteria:

    • 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
      • 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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Vitamin D-enriched pork

    One portion of Vitamin D-enriched pork

    Other: Pork arm

  • Placebo comparator
    Control pork

    One portion of control pork

    Other: Pork arm

  • Active comparator
    Vitamin D supplement

    Equivocal dose of Vitamin D supplement

    Other: Pork arm

  • Experimental
    Vitamin D-enriched chicken

    One portion of Vitamin D-enriched chicken

    Other: Chicken arm

  • Placebo comparator
    Control chicken

    One portion of control chicken

    Other: Chicken arm

Interventions

  • OtherPork arm

    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.

  • OtherChicken arm

    The effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken.

06

What researchers measure

Primary outcomes

  1. Change in vitamin D concentration

    Vitamin D3, vitamin D2, 25(OH)D3, 25(OH)D2) (nmol/L) in serum/plasma

    Time frame: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)

Secondary outcomes

  1. Calcium serum concentrations

    Adjusted calcium

    Time frame: Monitored over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)

  2. Parathyroid hormone (PTH) concentration

    Plasma levels

    Time frame: Change over 24 hours (baseline (0 hr), 1.5, 3, 6, 9, 24-hour)

07

Study locations

1 site
  • Human Intervention Studies Unit, Ulster University
    Coleraine, Co.Londonderry BT52 1SA, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04207294
Lead sponsor
University of Ulster
Collaborators
Devenish Nutrition, Lagan House, 19 Clarendon Road, Belfast, BT1 3BG, Agri-Food and Biosciences Institute (AFBI), 18a Newforge Lane, Belfast, BT9 5P
Responsible party
Sponsor
First posted
Dec 20, 2019
Start date
Jan 16, 2020
Primary completion
Apr 10, 2020
Completion
Apr 10, 2020
Last update
Jun 14, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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