Recruiting

Vitamin D3 Eggs

Sponsor:

Cornell University

Code:

NCT07859280

Conditions

Healthy Adult Participants

Vitamin D Insufficiency

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Vitamin D3 bioenhanced eggs

25(OH)D3 bioenhanced eggs

Study Details

Brief summary:

The purpose of this research is to evaluate if 1) consumption of vitamin D3- or 25(OH)D3-biofortified eggs will increase vitamin D and 25(OH)D status in young adults who consume these bioenhanced eggs, 2) to determine if the gut microbiome profile is associated with 25(OH)D or vitamin D status and 3) to evaluate possible changes in the gut microbiome following an 8-week supplementation period providing 5(OH)D- or vitamin D bioenhanced eggs.

Conditions

Healthy Adult Participants

Vitamin D Insufficiency

Study ID

NCT07859280

Start date

Jan, 2027

Status verified date

Sep, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy adults
  • Non-smoking
  • Age between 18- 40 years
  • Females: premenopausal and not pregnant or lactating
  • Body mass index (BMI) between 18.5-27.0 kg/m2.
  • No planned trip(s) to lower latitudes during the 8-week study

Exclusion Criteria:

  • BMI <18.5 or > 27.0 kg/m2,
  • Age <18 y or > 40y,
  • Smoking
  • Pregnancy, lactating
  • Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/use of medications known to impact vitamin D and 25(OH)D absorption
  • Been prescribed antibiotics within 3 months before enrolling
  • History or current diagnosis of any of the following conditions: intestinal problems (cystic fibrosis, Crohn's Disease, IBD, etc.), blood disorders (sickle cell, thalassemia, etc.), stomach problems (ulcers or other problems requiring antacids), joint diseases requiring anti-inflammatory medication, or asthma.
  • Planned trip(s) to lower latitudes during the 8-week study

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Vitamin D3 bioenhanced eggs

experimental: 25(OH)D3 bioenhanced eggs

Interventions

Vitamin D3 bioenhanced eggs

Six vitamin D3-fortified eggs per week will be provided to participants to consume each week for 8 weeks

25(OH)D3 bioenhanced eggs

Six 25(OH)D3-fortified eggs will per week be provided to participants to consume each week for 8 weeks.

Primary outcome measure

  • Vitamin D Status [ Time Frame: Baseline, and time course of week 2, week 4, week 6, week 8 ]
  • Gut microbiome composition [ Time Frame: Baseline, week 4, week 8 ]

Central Contacts and Locations

Central contacts

Kimberly O'Brien, PhD

(607) 255-3743koo4@cornell.edu

Locations

Human Metabolic Research Unit

Recruiting

Ithaca, New York, United States, 14850

Contacts

Jennifer Thompson, NP

215-565-6742jjt226@cornell.edu

More Information

Sponsor

Cornell University

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • Vitamin D
  • Biofortified eggs
  • Gut microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Cornell University on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.