[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06983730":3,"trial-entities:NCT06983730":109,"trial-summary:NCT06983730":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":43,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":75,"locations":77,"central_contacts":103,"overall_officials":105,"references":107,"see_also_links":108},"NCT06983730","2024P000637","The Kidney's Response to Exercise in Heat, and the Impact of Vitamin B3 on This Response","Development of a Clinical Experimental Heat Stress Protocol and Exploration of the Effect of Niacinamide on Physiologic, Metabolic, and Biochemical Responses to Heat Stress","RECRUITING","2028-06","2026-02","2026-02-05","2026-01-26","Beth Israel Deaconess Medical Center","OTHER",true,"The goal of this clinical trial is to learn about the processes occurring in the kidneys while under heat stress in healthy volunteers. The main questions it aims to answer are:\n\n* How do the chemicals produced by the body change under conditions of higher versus lower heat stress?\n* What role does a specific area of the body's metabolism, known as NAD+ metabolism, play in the body's response to heat stress, and can this response be modified by taking vitamin B3?","To answer these questions, researchers will compare the chemical changes in each participant under progressively higher levels of heat stress, and while taking either vitamin B3 or a placebo.\n\nThis clinical trial will occur in two stages. Participants may choose participate in stage 1 only, stage 2 only, or both parts of this clinical trial.\n\nDuring stage 1, participants will exercise using a stationary rowing ergometer in a hot and humid environmental chamber for three sessions, each session separated by about a week.\n\n* Each session, they will be asked to work out at a progressively higher intensity with climate conditions kept the same in the chamber.\n* More intense exercise produces greater heat stress, resulting in lower, moderate, and higher levels of heat stress exposure across the three sessions.\n* Researchers will see how chemicals in the blood and urine, along with physical measurements like heart rate and body temperature, change across these different levels of heat stress.\n\nDuring stage 2, participants will exercise using the same rowing ergometer in the same environmental chamber. They will do this for two sessions, each separated by about a week.\n\n* One of the sessions each participant will take vitamin B3, and the other session each participant will take placebo.\n* Heat stress exposure will be the same each session.\n* Researchers will again see how chemicals in the blood and urine, along with physical measurements like heart rate and body temperature, differ between sessions with vitamin B3 and sessions with placebo",[19,20,21],"Heat Strain","Healthy Volunteer Study","Kidney Dysfunction",[23,24,25,26],"NAD+","Niacinamide","Vitamin B3","Experimental heat strain","INTERVENTIONAL","BASIC_SCIENCE",[30],"EARLY_PHASE1",{"count":32,"type":33},28,"ESTIMATED",[35],{"type":36,"name":25,"description":37,"armGroupLabels":38,"otherNames":41},"DIETARY_SUPPLEMENT","1000mg once a day orally for two days, once the day before the exercise session, and once the day of the exercise session.",[39,40],"Placebo, then vitamin B3","Vitamin B3, then placebo",[42],"niacinamide",[44,48],{"measure":45,"description":46,"timeFrame":47},"Urinary neutrophil gelatinase-associated lipocalin","Marker of stress and injury in the kidney","Pre- and immediately post- heat stress exposure",{"measure":49,"description":50,"timeFrame":47},"Urinary TIMP2 (tissue inhibitor of metalloproteinase-2) and IGFBP7 (insulin-like growth factor-binding protein 7)","Marker of kidney stress and injury",[52,55],{"measure":53,"description":54,"timeFrame":47},"Urine Quinolinate to Tryptophan Ratio","Ratio of quinolinate to tryptophan in the urine",{"measure":56,"description":57,"timeFrame":47},"Serum creatinine","Marker of kidney function","ALL","18 Years","45 Years",{"inclusion":62,"exclusion":70,"raw_text":74},[63,64,65,66,67,68,69],"Healthy volunteer","Any race","Estimated glomerular filtration rate greater than 90 ml\u002Fmin\u002F1.73m2","Urine albumin\u002Fcreatinine ratio less than 30mg\u002Fg","Nonsmoker","No regular dietary supplements, particularly vitamin B3","Physically fit, defined as having a VO2 max of between 35 and 60mL\u002Fkg\u002Fmin",[71,72,73],"Medical condition preventing safe participation in exercise during heat","Allergy to Vitamin B3","Severe food allergies or dietary restrictions that would preclude eating the planned study diet without major modifications","Inclusion Criteria:\n\n* Healthy volunteer\n* Any race\n* Estimated glomerular filtration rate greater than 90 ml\u002Fmin\u002F1.73m2\n* Urine albumin\u002Fcreatinine ratio less than 30mg\u002Fg\n* Nonsmoker\n* No regular dietary supplements, particularly vitamin B3\n* Physically fit, defined as having a VO2 max of between 35 and 60mL\u002Fkg\u002Fmin\n\nExclusion Criteria:\n\n* Medical condition preventing safe participation in exercise during heat\n* Allergy to Vitamin B3\n* Severe food allergies or dietary restrictions that would preclude eating the planned study diet without major modifications",[76],"ADULT",[78,94],{"facility":13,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":91},"Boston","Massachusetts","02215","United States",[84,89],{"name":85,"role":86,"phone":87,"email":88},"Nathan H Raines, MD MPH","CONTACT","703-927-0992","nraines@bidmc.harvard.edu",{"name":85,"role":90},"PRINCIPAL_INVESTIGATOR",{"lat":92,"lon":93},42.35843,-71.05977,{"facility":95,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":96,"geoPoint":102},"Boston University",[97,101],{"name":98,"role":86,"phone":99,"email":100},"Dustin Allen, PhD","417-693-2182","drallen@bu.edu",{"name":98,"role":90},{"lat":92,"lon":93},[104],{"name":85,"role":86,"phone":87,"email":88},[106],{"name":85,"affiliation":13,"role":90},[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Healthy Volunteer",[],{"nct_id":4,"found":15,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study planning to enroll 28 healthy volunteers. It involves comparing chemical changes in participants under different heat stress levels and when taking either Vitamin B3 or a placebo.","completed","Kidney's Response to Exercise in Heat and Vitamin B3","This study is looking at how your kidneys respond to exercise in hot conditions and if Vitamin B3 (1000mg once a day for two days) can change that response. Researchers want to understand how chemicals in your body change under different levels of heat stress and if Vitamin B3 plays a role. You might be able to join if you are a healthy volunteer between 18 and 45 years old, a non-smoker, and physically fit. You also need to have healthy kidney function, as shown by specific blood and urine tests. The study will measure certain kidney markers (Urinary neutrophil gelatinase-associated lipocalin, Urinary TIMP2, and IGFBP7) before and right after heat exposure to see the impact. The current recruitment status is unclear.","Kidney markers are measured immediately after heat stress exposure, but no further follow-up is specified.",122,"You would participate in two stages, potentially involving up to five exercise sessions on a rowing machine in a hot and humid room, each session separated by about a week.","Not stated in the trial record.",[25],"v2"]