[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658959":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":29,"studyPopulation":17,"armGroups":30,"interventions":40,"overallOfficials":17,"centralContacts":48,"locations":54,"responsibleParty":74,"collaborators":17,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":17,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":57,"whyStopped":17,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Cornell University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Vitamin D Status","Serum concentrations of vitamin D2, vitamin D3, 25(OH)D2, 25(OH)D3, 1,25(OH)2D2, 1,25(OH)2D3, 24,25(OH)2D3, and vitamin D binding protein concentration will be measured biweekly over 8 weeks to assess vitamin D and 25(OH)D bioavailability.","Baseline, and time course of week 2, week 4, week 6, week 8",{"measure":14,"description":15,"timeFrame":16},"Gut microbiome composition","Fecal samples will be collected for metagenomic analyses to evaluate the impact of vitamin D or 25(OH)D status and intake on the gut microbiome.","Baseline, week 4, week 8",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","BASIC_SCIENCE",{"masking":23,"maskingDescription":17,"whoMasked":24},"QUADRUPLE",[25,26,27,28],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","In the wintertime, decreased UVB exposure limits vitamin D synthesis. Vitamin D insufficiency is common in the US and globally, with insufficiency evident in 41% of US adults over the age of 18 years, and has been linked to several adverse health outcomes. While dairy products are the major source of dietary vitamin D intake for the US public, little attention has been placed on other animal products (meat or eggs) as a source of vitamin D3 and 25(OH)D3. Determining the bioavailability of vitamin D-fortified eggs can inform updated dietary guidelines.\n\nDecreased 25(OH)D status has also been associated with a less diverse gut microbiome. Additionally, little attention has been given to how bioenhanced foods containing vitamin D3 or 25(OH)D3 may differentially shape the gut microbiome and thus human vitamin D metabolism. Prior research shows a strong correlation between 1,25(OH)2D3 concentration and gut microbial diversity in elderly men. Further research will help inform recommendations that address the efficacy of the form of vitamin D ingested from food products and how vitamin D status may shape the gut microbiota.",[31,36],{"label":32,"type":33,"description":17,"interventionNames":34},"Vitamin D3 bioenhanced eggs","EXPERIMENTAL",[35],"Dietary Supplement: Vitamin D3 bioenhanced eggs",{"label":37,"type":33,"description":17,"interventionNames":38},"25(OH)D3 bioenhanced eggs",[39],"Dietary Supplement: 25(OH)D3 bioenhanced eggs",[41,45],{"type":42,"name":32,"description":43,"armGroupLabels":44,"otherNames":17},"DIETARY_SUPPLEMENT","Six vitamin D3-fortified eggs per week will be provided to participants to consume each week for 8 weeks",[32],{"type":42,"name":37,"description":46,"armGroupLabels":47,"otherNames":17},"Six 25(OH)D3-fortified eggs will per week be provided to participants to consume each week for 8 weeks.",[37],[49],{"name":50,"role":51,"phone":52,"phoneExt":17,"email":53},"Kimberly O'Brien, PhD","CONTACT","(607) 255-3743","koo4@cornell.edu",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Human Metabolic Research Unit","RECRUITING","Ithaca","New York","14850","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-76.49661,42.44063,{"lat":67,"lon":66},[70],{"name":71,"role":51,"phone":72,"phoneExt":17,"email":73},"Jennifer Thompson, NP","215-565-6742","jjt226@cornell.edu",{"type":75,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100658959","supplementation-of-cholecalciferol-and-related-active-metabolites-through-bioenhancing-layers-eggs-100658959",false,"NCT07859280","Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs","Biofortified Vitamin D Metabolites in Eggs and Their Impact on Vitamin D Status and the Gut Microbiome","SCRAMBLE","Inclusion Criteria:\n\n* Healthy adults\n* Non-smoking\n* Age between 18- 40 years\n* Females: premenopausal and not pregnant or lactating\n* Body mass index (BMI) between 18.5-27.0 kg\u002Fm2.\n* No planned trip(s) to lower latitudes during the 8-week study\n\nExclusion Criteria:\n\n* BMI \\\u003C18.5 or \\> 27.0 kg\u002Fm2,\n* Age \\\u003C18 y or \\> 40y,\n* Smoking\n* Pregnancy, lactating\n* Have gastrointestinal disorders\u002Fmalabsorption diseases\u002Fdietary restrictions\u002Fuse of medications known to impact vitamin D and 25(OH)D absorption\n* Been prescribed antibiotics within 3 months before enrolling\n* 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.\n* Planned trip(s) to lower latitudes during the 8-week study",true,"ALL","18 Years","40 Years",{"count":89,"type":90},60,"ESTIMATED","INTERVENTIONAL",[93],"NA","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.",[96,97],"Healthy Adult Participants","Vitamin D Insufficiency",[99,100,101],"Vitamin D","Biofortified eggs","Gut microbiome","2026-09-29",{"date":104,"type":105},"2026-10-05","ACTUAL",{"date":107,"type":90},"2027-01",{"date":109,"type":90},"2029-12",{"name":5,"class":6},1]