[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653825":3},{"organization":4,"outcomesModule":7,"designInfo":97,"detailedDescription":100,"studyPopulation":100,"armGroups":110,"interventions":141,"overallOfficials":168,"centralContacts":173,"locations":178,"responsibleParty":197,"collaborators":100,"id":199,"slug":200,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":207,"sex":208,"minAge":209,"maxAge":100,"enrollmentInfo":210,"targetDuration":100,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":180,"whyStopped":100,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"RDC Clinical Pty Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":75},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Part A: serum\u002Fplasma absorption (AUC) of the trial product t0-t168 (vitamin D3)","Baseline-corrected values in serum\u002Fplasma absorption (AUC) of the trial product t0-t168 (vitamin D3)","Baseline to day 7",{"measure":14,"description":15,"timeFrame":16},"Part A: serum\u002Fplasma absorption (AUC) of the trial product t0-t24 (omega-3)","Baseline-corrected values in serum\u002Fplasma absorption (AUC) of the trial product t0-t24 (omega-3)","Baseline to day 2",{"measure":18,"description":19,"timeFrame":20},"Part B: Baseline-corrected serum 25(OH)D AUC (0-6 weeks)","Baseline-corrected serum 25(OH)D AUC (0-6 weeks)","Baseline to 6 weeks",[22,26,29,33,37,40,43,45,47,51,54,57,61,64,67,70,72],{"measure":23,"description":24,"timeFrame":25},"Part A: Serum\u002Fplasma absorption (AUC) of the trial product t0-t8 (vitamin D3)","Serum\u002Fplasma absorption (AUC) of the trial product t0-t8 (vitamin D3)","Baseline to 8 hours",{"measure":27,"description":28,"timeFrame":16},"Part A: serum\u002Fplasma absorption (AUC) of the trial product t0-t24 (vitamin D3)","serum\u002Fplasma absorption (AUC) of the trial product t0-t24 (vitamin D3)",{"measure":30,"description":31,"timeFrame":32},"Part A: Serum\u002Fplasma absorption (AUC) of the trial product t0-t48 (vitamin D3)","Serum\u002Fplasma absorption (AUC) of the trial product t0-t48 (vitamin D3)","Baseline to day 3",{"measure":34,"description":35,"timeFrame":36},"Part A: Serum\u002Fplasma absorption (AUC) of the trial product t0-t10 (omega-3)","Serum\u002Fplasma absorption (AUC) of the trial product t0-t10 (omega-3)","Baseline to 10hours",{"measure":38,"description":39,"timeFrame":12},"Part A: Change and absolute Tmax (vitamin D)","Change and absolute Tmax",{"measure":41,"description":42,"timeFrame":12},"Part A: Change and absolute Cmax (vitamin D)","Change and absolute Cmax",{"measure":44,"description":39,"timeFrame":16},"Part A: Change and absolute Tmax (omega-3)",{"measure":46,"description":42,"timeFrame":16},"Part A: Change and absolute Cmax (omega-3)",{"measure":48,"description":49,"timeFrame":50},"Part A: Participant demographics","Participant demographics","Baseline",{"measure":52,"description":53,"timeFrame":12},"Part A: Tolerability","Tolerability",{"measure":55,"description":56,"timeFrame":12},"Part A: Safety via AE monitoring","Safety via AE monitoring",{"measure":58,"description":59,"timeFrame":60},"Part B: Change from baseline at week 6, standard vs enhanced formulation","Change from baseline at week 6, standard vs enhanced formulation","Baseline to week 6",{"measure":62,"description":63,"timeFrame":60},"Part B: Weekly 25(OH)D change","Weekly 25(OH)D change",{"measure":65,"description":66,"timeFrame":60},"Part B: Weekly cholecalciferol change","Weekly cholecalciferol change",{"measure":68,"description":69,"timeFrame":50},"Part B: Demographics","Demographics",{"measure":71,"description":53,"timeFrame":60},"Part B: Tolerability",{"measure":73,"description":74,"timeFrame":60},"Part B: Safety (E\u002FLFT)","Safety (E\u002FLFT)",[76,79,82,85,88,91,94],{"measure":77,"description":78,"timeFrame":60},"Part B (exploratory): parathyroid hormone","Change from baseline to week 6 in parathyroid hormone (PTH)",{"measure":80,"description":81,"timeFrame":60},"Part B (exploratory): calcium","Change from baseline to week 6 in calcium",{"measure":83,"description":84,"timeFrame":60},"Part B (exploratory): high-sensitivity C-reactive protein","Change from baseline to week 6 in high-sensitivity C-reactive protein (hs-CRP)",{"measure":86,"description":87,"timeFrame":60},"Part B (exploratory): interleukin-6 (IL-6)","Change from baseline to week 6 in interleukin-6 (IL-6)",{"measure":89,"description":90,"timeFrame":60},"Part B (exploratory): interleukin-1b (IL-1b)","Change from baseline to week 6 in interleukin-1b (IL-1b)",{"measure":92,"description":93,"timeFrame":60},"Part B (exploratory): MCP-1 (Monocyte Chemoattractant Protein-1)","Change from baseline to week 6 in MCP-1 (Monocyte Chemoattractant Protein-1) also known as CCL2 (Chemokine (C-C motif) ligand 2)",{"measure":95,"description":96,"timeFrame":60},"Part B (exploratory): tumour necrosis factor-alpha (TNF-α)","Change from baseline to week 6 in tumour necrosis factor-alpha (TNF-α)\\].",{"allocation":98,"interventionModel":99,"interventionModelDescription":100,"primaryPurpose":101,"observationalModel":100,"timePerspective":100,"maskingInfo":102},"RANDOMIZED","PARALLEL",null,"OTHER",{"masking":103,"maskingDescription":104,"whoMasked":105},"QUADRUPLE","Double-blind omega-3 sub-study and a single-blind vitamin D3 sub-study, with blinded laboratory analysis and blinded statistical analysis",[106,107,108,109],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[111,117,123,128,132,137],{"label":112,"type":113,"description":114,"interventionNames":115},"Aquacelle® Omega 3","EXPERIMENTAL","Participants will have a single dose containing 315mg EPA and DHA.",[116],"Dietary Supplement: Aquacelle® Omega 3",{"label":118,"type":119,"description":120,"interventionNames":121},"Comparator Omega 3","ACTIVE_COMPARATOR","Participants will have a single dose containing 315mg EPA and DHA",[122],"Dietary Supplement: Comparator Omega 3",{"label":124,"type":113,"description":125,"interventionNames":126},"Plexosome® Vitamin D3","Participants will have 1000IU vitamin D3 each day for 7 days.",[127],"Dietary Supplement: Plexosome® Vitamin D3",{"label":129,"type":119,"description":125,"interventionNames":130},"Comparator Vitamin D3",[131],"Dietary Supplement: Comparator Vitamin D3",{"label":133,"type":113,"description":134,"interventionNames":135},"Plexosome® Vitamin D3 6 weeks","Participants will have 1000IU vitamin D3 each day for 6 weeks.",[136],"Dietary Supplement: Plexosome® Vitamin D3 6 weeks",{"label":138,"type":119,"description":134,"interventionNames":139},"Comparator Vitamin D3 6 weeks",[140],"Combination Product: Comparator Vitamin D3 6 weeks",[142,148,151,157,160,164],{"type":143,"name":112,"description":144,"armGroupLabels":145,"otherNames":146},"DIETARY_SUPPLEMENT","Participants will consume 1 capsule containing 315mg EPA and DHA",[112],[147],"Omega-3",{"type":143,"name":118,"description":144,"armGroupLabels":149,"otherNames":150},[118],[147],{"type":143,"name":124,"description":152,"armGroupLabels":153,"otherNames":154},"Participants will have 1000IU vitamin D3 each day for 7 days",[124],[155,156],"Cholecalciferol","Vitamin D3",{"type":143,"name":129,"description":152,"armGroupLabels":158,"otherNames":159},[129],[155,156],{"type":143,"name":133,"description":161,"armGroupLabels":162,"otherNames":163},"Participants will have 1000IU vitamin D3 each day for 6 weeks",[133],[155,156],{"type":165,"name":138,"description":161,"armGroupLabels":166,"otherNames":167},"COMBINATION_PRODUCT",[138],[155,156],[169],{"name":170,"affiliation":171,"role":172},"David Briskey","RDC Clinical","PRINCIPAL_INVESTIGATOR",[174],{"name":170,"role":175,"phone":176,"phoneExt":100,"email":177},"CONTACT","+61(0)731024486","research@rdcglobal.com.au",[179],{"facility":171,"status":180,"city":181,"state":182,"zip":183,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":191,"contacts":192},"RECRUITING","Fortitude Valley","Queensland","4006","Australia","AU",{"type":187,"coordinates":188},"Point",[189,190],153.03178,-27.45706,{"lat":190,"lon":189},[193,195],{"name":170,"role":175,"phone":194,"phoneExt":100,"email":177},"+61 (0) 731024486",{"name":196,"role":172,"phone":100,"phoneExt":100,"email":100},"David Briskey, PhD",{"type":198,"investigatorFullName":100,"investigatorTitle":100,"investigatorAffiliation":100,"oldNameTitle":100,"oldOrganization":100},"SPONSOR","100653825","phase-4-supplementation-absorption-comparison-100653825",false,"NCT07791797","Supplementation Absorption Comparison","Effect of Different Supplement Formulations on Nutrient Absorption in Otherwise Healthy Participants: a Randomised, Parallel-group Study With Double-blinded Omega-3 and Single-blinded Vitamin D3","PHAABS","Part A:\n\nInclusion Criteria:\n\n* Adults 18 years and older\n* Generally healthy\n* BMI 18.5-29.9 kg\u002Fm2\n* Able to provide informed consent\n* Agree to not participate in another clinical trial while enrolled in this trial\n* Agree not to change current diet and\u002For exercise frequency or intensity during entire study period\n* Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points\n\nExclusion Criteria:\n\n* Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions\n* Have an unstable illness e.g. diabetes and thyroid gland dysfunction\n* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years\n* Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)\n* Active smokers, nicotine use or drug (prescription or illegal substances) abuse\n* Chronic past and\u002For current alcohol use (\\>21 alcoholic drinks week)\n* Pregnant or lactating women\n* Allergic to any of the ingredients in enhanced or standard formula\n* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month (excluding RDC Clinical trials)\n* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion\n* Regular use within the past 4 weeks of supplements containing the trial product\n\nPart B:\n\nThe above criteria apply, plus baseline serum 25(OH)D \\\u003C20.0 ng\u002FmL (\\\u003C50.0 nm\u002FL)",true,"ALL","18 Years",{"count":211,"type":212},160,"ESTIMATED","INTERVENTIONAL",[215],"PHASE4","The goal of this interventional study is to compare the absorption of supplements with and without absorption enhancing technology in healthy volunteers. We will be testing vitamin D3 and omega 3 in both males and females 18 years and older. Part A will comprise of two arms receiving a single dose of omega-3 supplement, and two arms who will receive vitamin D3 supplement daily for 7 days. Part B comprises of two arms who will receive vitamin D3 supplement daily for 6 weeks.",[218],"Healthy Volunteer",[220,221,222],"absorption","vitamin D","omega-3","2026-09-06",{"date":225,"type":226},"2026-09-10","ACTUAL",{"date":228,"type":226},"2026-08-31",{"date":230,"type":212},"2027-09",{"name":5,"class":6},1]