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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK138320 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Boston University Charles River Campus | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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.
This 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.
During 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.
During 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B3, then placebo | Experimental | Individuals will receive 1000mg oral Vitamin B3 daily for two days leading up to their first exercise session, and oral placebo daily for two days leading up to their second exercise session. |
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| Placebo, then vitamin B3 | Experimental | Individuals will receive 1000mg oral placebo daily for two days leading up to their first exercise session, and oral vitamin B3 daily for two days leading up to their second exercise session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B3 | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Urinary neutrophil gelatinase-associated lipocalin | Marker of stress and injury in the kidney | Pre- and immediately post- heat stress exposure |
| Urinary TIMP2 (tissue inhibitor of metalloproteinase-2) and IGFBP7 (insulin-like growth factor-binding protein 7) | Marker of kidney stress and injury | Pre- and immediately post- heat stress exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Quinolinate to Tryptophan Ratio | Ratio of quinolinate to tryptophan in the urine | Pre- and immediately post- heat stress exposure |
| Serum creatinine | Marker of kidney function |
| Measure | Description | Time Frame |
|---|---|---|
| Urine and serum metabolites, including metabolites related to nicotinamide adenine dinucleotide (NAD+) | Other chemical byproducts of metabolism and exposure that may change during or impact the effect of heat stress, measured using mass spectrometry | Pre-, during, immediately post, and 24 hours post- heat stress exposure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathan H Raines, MD MPH | Contact | 703-927-0992 | nraines@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nathan H Raines, MD MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
De-identified individual participant data will be stored in the Harvard Dataverse Repository.
Data availability will begin at the time of an associated publication or the end of the performance period, whichever comes first. Data will continue to be available for ten years after completion of study activities.
Researchers may request controlled-access data using standard processes at the repository.
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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There are two phases to this study. The first phase is a dose-response phase evaluating the effect of experimental heat strain on kidney metabolic and stress response. The second phase uses this experimental heat strain at a dose producing kidney metabolic and stress response to conduct a crossover trial investigating how Vitamin B3 impacts the kidney's metabolic and stress response during heat strain.
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| Pre- and immediately post- heat stress exposure |
| Urine and serum nicotinamide levels |
Levels of the interventional supplement, vitamin B3 (nicotinamide) |
| Pre-, during, immediately post, and 24 hours post- heat stress exposure |
| Boston University | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |